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Tag: Pharmaceutical Companies

  • $650 Million Settlement Reached in Pradaxa Lawsuit

    Boehringer Ingelheim Pharmaceuticals this week agreed to a settlement in the multi-district litigation over the drug Pradaxa. The company has agreed to pay $650 million to settle the lawsuits. Much of that money will be used to compensate patients who claim they were injured by Pradaxa.

    Around 1,600 people had filed individual lawsuits against Boehringer Ingelheim over Pradaxa as of 2012. In August of that year a federal court consolidated the claims into a multi-district litigation, a type of proceeding that is typically quicker than a class action lawsuit and in which one judge is able to decide on many similar claims together. In addition, four state proceedings had been filed over the drug in California, Missouri, Delaware, and Connecticut. In total, around 4,000 Americans filed lawsuits against Boehringer Ingelheim claiming to have been harmed by Pradaxa.

    “We are pleased that today’s settlement will bring justice and financial assistance to those hurt while taking Pradaxa,” said Mikal Watts, a lawyer appointed co-lead counsel for all plaintiffs by the judge in the case. “We are proud of the settlement we have achieved, congratulate the company on doing the right thing, and look forward to distributing these funds to our clients as expeditiously as possible.”

    Pradaxa was approved by the U.S. Food and Drug Administration (FDA) in 2010 as an anticoagulant. Like other anticoagulants, Pradaxa was used as a blood thinner for patients at risk for stroke. Also like other anticoagulants, Pradaxa’s most common side effect is bleeding – particularly gastrointestinal bleeding. Elderly patients taking the drug were found by the FDA to die more often due to the drug’s side effects.

    The lawsuits claimed that Boehringer Ingelheim knew the drug was more dangerous than previously realized. Court documents showed that the company failed to inform the FDA that Pradaxa is more dangerous than pre-approval studies indicated and that company executives tried to silence an internal study that could have hurt sales of the drug.

    Image via the National Institutes of Health

  • Diabetes, Alzheimer’s Research May Yield Cures

    A new research project valued at roughly $230 million may yield the answers for curing Alzheimer’s, diabetes, lupus, and arthritis.

    Eight of the largest U.S. pharmaceutical companies are collaborating on the project with the National Institute of Health and the U.S. government to conduct extensive research on Alzheimer’s patients.

    Pfizer Inc., Eli Lilly & Co., Merck, Sanofi, Johnson & Johnson, Abbvie Inc., Biogen Idec Inc., Bristol-Myers Squibb Co., GlaxoSmithKline, and Takeda Pharmaceutical Co. are all participating in the joint effort, dividing the $230 million project costs evenly between themselves and the NIH.

    Upon the estimate that Alzheimer’s victims will triple in numbers by 2015, the U.S. government decided to try and eradicate the crippling illness once and for all. The treatments for – and costs incurred from – the debilitating disease cost the country billions of dollars each year, currently affecting more than 5 million people in the U.S.

    All research for determining an Alzheimer’s cure conducted previously has proven fruitless. Scientists at the top drug companies say that technology and science have not advanced far enough yet for a cure to be feasible. In the last two years, alone, two of the nation’s top companies each lost a substantial amount of funds from unsuccessful ventures into potential treatments for curing the disease.

    Now, the evidence pointing to a possible solution for ending Alzheimer’s has become available, with researchers being able to pinpoint common “biomarkers” in tissue samples taken from Alzheimer’s patients, the keys to finding possible drug targets.

    The NIH says that this first round of research – on Alzheimer’s – is expected to last about three to five years; should it end successfully, there is a very good chance that lupus, diabetes, and arthritis will also be explored.

    However, new advancements in diabetes research has potentially slowed the severe need for studies to be conducted on diabetic patients to attempt to find a cure.

    An associate professor of biomedical engineering at Boston University, Ed Damiano, has joined together with Harvard Medical School assistant professor, Dr. Steven Russell, to develop a bionic pancreas that allows diabetics to live normal lives. The pancreas, which has been tested in groups of both adults and children, has been a success in regulating blood sugar levels without the patient having to inject insulin and keep a constant check on their own levels.

    The “pancreas” has now been developed into something as small as a playing card, according to USA TODAY, checking and regulating blood sugar on its own through a continuous glucose monitor.

    The monitor, which was first controlled by a laptop, is now controlled through an app on the iPhone, which is alerted when blood sugar levels need to be adjusted. The app then signals to the monitor that it needs to calculate how much of the blood sugar-regulating hormones, insulin and glucagon, the patient needs. The pancreas then releases the hormone on it’s own, after being given the necessary amount(s) needed by the monitor.

    Type 1 diabetic Scott Scolnick, who participated in the trials, says that the device has “changed his life,” proving that no matter what or when he eats, his blood sugar will remain at a safe and healthy level.

    Says Scolnick, “It’s been the most freeing experience I ever had in my life.”

    Damiano, whose son was diagnosed with Type 1 diabetes when he almost a year old, vowed to his child that by the time his son left for college, his dad would have created a bionic pancreas. Damiano’s son, now a teenager, is about four years away from leaving for college. Damiano says that a promise is a promise, and that his vow to his son is one in which he intends to keep.

    Damiano and Russell hope to have the pancreas approved by the FDA by 2017.

    Main image courtesy @WSJ via Twitter.

  • Johnson & Johnson to Pay $2.2 Billion Over Risperdal Claims

    The U.S. Department of Justice and the U.S. Food and Drug Administration (FDA) today announced that Janssen Pharmaceuticals has plead guilty over the misbranding of the drug Risperdal. Janssen and its company, Johnson & Johnson, will pay a total of $2.2 billion to settle the matter.

    Around $485 million of the amount will be paid in the form of a criminal fines and forfeitures, while the other $1.72 billion is part of civil case settlement with the U.S. federal and several state governments. In addition, the company will also have to comply with a corporate integrity agreement put together by the U.S. Department of Health and Human Services’ Office of the Inspector General.

    “The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Eric Holder, U.S. Attorney General. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”

    The drug in question, Risperdal, has been approved by the FDA for the treatment of schizophrenia and the short-term treatment of manic episodes in those with Bipolar Disorder. Janssen has admitted to marketing the drug to doctors for the treatment of agitation associated with elderly dementia – a use for which Risperdal is not FDA approved.

    The Justice Department claims that both Janssen and Johnson & Johnson downplayed the increased risk of stroke that the drug could cause in elderly patients and that they paid kickbacks to doctors who prescribed Risperdal. The companies had received multiple warnings about their marketing of Risperdal.

    The criminal investigation into Janssen’s Risperdal marketing practices began after a whistle-blower complaint was filed with the FDA.

    “When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications,” said Dr. Margaret Hamburg, FDA Commissioner. “The FDA relies on data from rigorous scientific research to define and approve the uses for which a drug has been shown to be safe and effective. Today’s announcement demonstrates that pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril.”

  • Cholesterol Drug Tredaptive Pulled Worldwide

    Less than one month ago, Merck, a major U.S. pharmaceutical company, announced that its cholesterol drug Tredaptive failed a major clinical trial. The drug is meant to improve heart health by increasing levels of “good” cholesterol, but the trial found that patients on the drug did not have a reduced risk of heart attack, stroke, necessary bypass surgery, or death, and were actually found to have an increased risk for serious, though non-fatal, side-effects.

    Merck announced this week that it is suspending the availability of Tredaptive worldwide. The decision is in line with a recommendation from the European medicine Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). The company has recommended that doctors stop prescribing Tredaptive and discontinue treatment with the drug for patients currently taking it. Merck is contacting regulatory agencies in countries where the drug is available, working with them to contact health care providers and pull Tredaptive.

    “Patients currently taking Tredaptive are our priority, and we are committed to continue to work with regulatory agencies around the world to ensure that physicians have appropriate information as we take steps to suspend the availability of Tredaptive,” said Dr. Michael Rosenblatt, Chief Medical Officer at Merck.

    Tredaptive is approved in around 70 countries, and is available in around 40 countries, including many in Europe. Its trade names include Pelzont, Trevaclyn, and Cordaptive. Merck sold $13 million worth of Tredaptive in the first three quarters of 2012.

  • Diabetes Drug Approved by U.S. FDA Committee

    A U.S. Food and Drug Administration (FDA) committee this week approved the drug canagliflozin for the treatment of adults with type 2 diabetes. The Endrocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 10 to 5 to approve the drug.

    Canagliflozin, which Johnson & Johnson has given the proposed trade name of Invokana, will, if further approved by the FDA later this year, be the first of a new type of diabetes drugs to be available in the U.S. It is a selective glucose co-transporter 2 inhibitor that blocks the reabsorption of glucose by the kidneys, which increases glucose excretion and lowers blood glucose levels. People with type 2 diabetes have kidneys that reabsorb greater-than-normal amounts of glucose back into the body.

    “We are pleased with the positive recommendation from the committee and look forward to working with the FDA to bring this important new therapy to patients in the U.S. to help them manage their type 2 diabetes,” said Dr. Peter Stein, head of the Metabolism Development and Diabetes Disease Area departments at Janssen Research & Development, the Johnson & Johnson R&D company that developed the drug. “Today’s outcome represents an important step toward achieving that goal.”

    The approval came after the results of a phase 3 clinical trial were presented at diabetes conferences last year. According to Janssen, the trial, which looked at 10,285 patients, was the “largest late-stage development program for an investigational pharmacologic product for the treatment of type 2 diabetes” ever submitted to health authorities. The results showed that canagliflozin improved glycemic control and was associated with weight loss and lower blood pressure. The side effects of the drug included yeast infections and urinary tract infections.

  • Stroke Medication Approved by the U.S. FDA

    Stroke Medication Approved by the U.S. FDA

    A new anti-clotting drug has been approved by the U.S. Food and Drug Administration. Called apixaban and marketed by Bristol-Myers Squibb and Pfizer as Eliquis, the drug has been approved to reduce the risk of stroke and blood clots for patients with an irregular heart beat that is not caused by a heart valve problem.

    “Blood clots in the heart can cause a disabling stroke if the clots travel to the brain,” said Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming.”

    Eliquis was approved following a safety and efficacy clinical trial that compared the drug to another anti-clotting drug called warfarin. The trial, which looked at over 18,000 patients, found that patients on Eliquis had fewer strokes than those on warfarin.

    The medication is not, however, for those who have heart valve problems. Likewise, patients with prosthetic heart valves are not recommended to take the new drug, as they were not part of the clinical trial. As with most anti-clotting drugs, bleeding uncontrollably is the biggest risk for those on Eliquis, as the FDA states there is no agent that can reverse the drug’s anti-coagulant effects.

    “With a population that is living longer, the prevalence of nonvalvular atrial fibrillation is increasing, but many patients are still not being managed effectively with warfarin,” said Dr. Christopher Granger, lead investigator on the Eliquis trial and a professor of medicine at the Duke Clinical Research Institute. “Eliquis represents a significant advance over warfarin for health care professionals to reduce the risk of stroke in patients with nonvalvular atrial fibrillation.”

  • Merck Drug Fails Major Clinical Trial

    Merck, a major U.S. pharmaceutical company, announced this week that its drug “Tredaptive” has failed a clinical trial. The trial was meant to test the drug for its ability to improve patients’ heart health by increasing their levels of “good” cholesterol.

    The trial, conducted at Oxford University and funded by Merck, looked at 25,673 patients at high risk for heart attack. The patients were given either Tredaptive or placed on standard stating therapy and followed for a median of 3.9 years.

    Researchers found that the drug did not reduce the patients’ risk for heart attacks, strokes, necessary bypass surgeries, or death due to heart attack. Worse still, patients in the trial were found to have an increased risk for “serious,” though non-fatal, side effects.

    “While we are disappointed in these results, we thank the investigators who have conducted the study and the patients who have participated in it,” said Peter Kim, president of Merck Research Laboratories. “We are committed to working closely with the independent research team at Oxford University and with regulatory agencies to understand the results and determine next steps.”

    Tredaptive, also marketed as Cordaptive, Pelzont, and Trevaclyn, is already approved in around 70 countries, including some in Europe. It is already sold in around 40 countries, and saw $13 million in sales during the first three quarters of 2012. Merck is now sharing the results of the trial with regulators in the countries where the drug is approved.

  • Asthma Drug Rejected by U.K.’s NICE

    Asthma Drug Rejected by U.K.’s NICE

    The U.K.’s National Institute for Health and Clinical Excellence (NICE) this weekend issued a draft guidance stating that it does not recommend omalizumab, an asthma medication marketed as Xolair by Novartis Pharmaceuticals. NICE is a U.K. health authority that publishes guidelines for the National Health Service.

    Omalizumab currently has a U.K. marketing authorization as an add-on therapy for persistent allergic asthma in adults and children. It works by blocking immunoglobulin E antibodies from attaching to allergens.

    NICE stated that new evidence, including new mortality data, that has be come available influenced its decision. It also took into account the dosing schedule for the drug, and the effect that had on its cost effectiveness. These factors and other “uncertainties in the evidence and analysis presented,” influenced NICE to withhold a recommendation for omalizumab. The health-related quality of life benefits of the drug are not currently considered quantifiable, and were not part of the economic modeling used by NICE.

    “The Committee is aware that severe, persistent allergic asthma can have a detrimental effect on a person’s life and that omalizumab is an effective therapy for children, adolescents and adults with severe persistent allergic asthma,” said Sir Andrew Dillon, chief executive of NICE. “But new evidence that has become available since our original appraisal of omalizumab in 2007 indicates that it is not as clinically or cost-effective as was first thought. The Committee explored ways to identify a subgroup of people for whom omalizumab might provide a cost effective treatment, including using favorable assumptions in the modeling. In addition, the Committee recognized that there could be additional health-related benefits for patients and carers as a result of using omalizumab. However, there was no quantifiable data relating to these benefits. Unfortunately, the Committee was unable to continue to recommend omalizumab for use in the NHS. The next step is for the manufacturer and other consultees to respond to the Committee’s concerns.”

  • Arthritis Drug Approved by the U.S. FDA

    Arthritis Drug Approved by the U.S. FDA

    The U.S. Food and Drug Administration this week approved Xeljanz (tofacitinib) for the treatment of moderate to severe rheumatoid arthritis (RA) in adults who have not responded to methotrexate.

    The twice-daily pill works by blocking molecules known as “Janus kinases.” The approval was based on the medication’s approval was based on its demonstrated effectiveness and safety in seven clinical trials. In all of the trials, adults with moderate to severe RA “experienced improvement in clinical response and physical functioning” when treated with Xeljanz. The drug was, however, associated with an increased increases in cholesterol and an increased risk of serious infections, including tuberculosis, cancers, and lymphoma.

    “RA is a serious and disabling disease that affects people in their everyday lives, and many patients do not adequately respond or are intolerant to currently available therapies,” said Dr. Stanley Cohen, study investigator and clinical professor of rheumatology at the University of Texas Southwestern Medical School. “In clinical trials, Xeljanz significantly reduced the signs and symptoms of RA and improved physical function. As a physician, I am pleased that we have another choice for patients living with inadequately controlled, moderately to severely active RA.”

    According to the FDA, RA is an autoimmune disease in which the body’s immune system attacks healthy tissue, leading to the inflammation of joints. The U.S. Centers for Disease Control and Prevention (CDC) estimates that it affects 1.5 million Americans.

    Xeljanz was developed by Pfizer, and the company has agreed to conduct post-marketing clinical trials to evaluate the long-term safety of the drug.

  • Multiple Sclerosis Drug ‘Reboots’ the Immune System

    Multiple Sclerosis Drug ‘Reboots’ the Immune System

    New trials show that a cancer drug can be an effective treatment for multiple sclerosis (MS) by ‘rebooting’ patients’ immune systems. The results of two phase III clinical trials were published today in the journal The Lancet.

    The trials, sponsored by Genzyme and Bayer Schering Pharma, found that for patients who recently relapsed, using a drug called alemtuzumab saw new episodes reduced by 49% over standard treatment and 65% of them remained relapse free compared to 47% of those on standard MS treatments. In addition, alemtuzumab was found to reduce the risk of acquiring disability by 42% over standard treatments.

    “Our research shows the transformative effect that alemtuzumab can have for people with MS,” said Alastair Coompston, principal investigator on both studies and professor at the University of Cambridge. “Patients who continue to show disease activity while on their initial therapy are especially difficult to treat. Now, we have shown that alemtuzumab works where first-line drugs have already failed. It not only reduces the chances of disability associated with MS but may even result in long-term clinical improvements.”

    The CARE MS II trial looked at 840 MS patients who had previously been treated but relapsed during therapy. They received either alemtuzumab or interferon beta-1a treatments. They had check-ups every three months for two years and yearly brain scans.

    The CARE MS I trial looked at 581 patients who were not previously treated for MS. As in the other trial, the patients received either alemtuzumab or interferon beta-1a treatments and were monitored for two years. It found that alemtuzumab reduced MS relapses 55% over the standard treatment.

    “Although alemtuzumab causes potentially serious side-effects, these can be identified and treated provided a monitoring schedule is carefully followed,” said Dr. Alasdair Coles, lead author of the study based on the trials and a clinician at the University of Cambridge. “Additionally, we think that we can identify which patients are at risk of autoimmune disease after alemtuzumab, and we are currently recruiting for a clinical trial which will explore whether we can use a drug to reduce the risk of autoimmunity in those at highest risk.”

  • Cholesterol Drug Wins FDA Recommendation

    Cholesterol Drug Wins FDA Recommendation

    Isis Pharmaceuticals recently announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) found the company’s drug, Kynamro (the trade name for mipomersen sodium) has been demonstrated to exhibit “sufficient” efficacy and safety for the treatment of Homozygous Familial Hypercholesterolemia (HoFH). HoFH is an aggressive, genetic cardiovascular disorder characterized by high levels of “bad” cholesterol, or low-density lipoprotein.

    The committee voted 9 to 6 to recommend Kynamro, and Isis will include the recommendation in its application for FDA approval. Though the vote will be considered when the drug is reviewed, the FDA is not bound by the recommendation.

    “We are very encouraged by the support for Kynamro at today’s Advisory Committee meeting, which marks a significant and positive step in our efforts to bring this important new therapy to patients and families affected by this often unrecognized genetic disorder,” said David Meeker, President and CEO of Genzyme, Isis’ marketing partner for the new drug. “There is still a great need for the HoFH patients, who have exhausted conventional medications and still have LDL cholesterol levels 2 to 4 times above normal. Genzyme looks forward to working with the FDA as it completes its review of the Kynamro application.”

    In making its decision, the committee reviewed data from a phase 3 study of Kynamro in HoFH patients, three other “supportive ” phase 3 studies of high-risk hypercholesterolemia patients, and and ongoing long term extension study

  • Cancer Treatment Kevetrin Begins Clinical Trials

    Today the Cellceutix Corporation announced that its new anti-cancer drug candidate Kevetrin will soon be entering clinical trials at the Harvard Cancer Center’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. Cellceutix is a biopharmaceutical company focused on small molecule drugs for the treatment of “unmet” medical conditions, such as drug-resistant cancers and autoimmune diseases.

    Kevetrin is Cellceutix’s name for the compound Thioureidobutyronitrile. The Cellceutix website states that the drug activates the “guardian angel gene” p53, which plays a role in controlling cell mutations. P53, in more than 50% of all human carcinomas, is limited in its ability to fight tumors by mutations. The company states that animal model experiments in drug-resistant cancers have been “excellent.”

    The Harvard Cancer Center is now ready to begin recruiting patients who have refractory solid tumors for the trial. The trial is a Phase I trial, meaning testing is at a very early stage. These clinical trials wil look at pharmacokinetics (what the human body does with the drug), pharmacodynamics (what the drug does to the body), tolerance, safety, and the maximum tolerated dose for the drug. About 40 patients will be enrolled for the “dose escalation” part of the study, with the possibility of up to 12 more being recruited for dosage saftey and pharmacodynamics testing.

  • Lung Cancer Drug Trial Cancelled

    Lung Cancer Drug Trial Cancelled

    This week, ArQule, a biotechnology company focused on developing “next-generation” small-molecule cancer drugs, announced that a drug trial for a lung cancer treatment it developed has been stopped early.

    The independent Data Monitoring Committee (DMC) overseeing the Phase 3 trial recommended that the study be halted following an interim analysis that concluded the trial would not show improved overall survival for patients.

    The study looked at around 1,000 patients from over 200 sites worldwide. It was a randomized, double-blind, controlled trial that investigated the drug tivantinib in conjunction with erlotinib. Tivantinib was co-developed by ArQule and the Japanese pharmaceutical company Daiichi Sankyo. The patients were all previously treated, and had locally advanced or metastatic, non-squamous, non-small cell lung cancer.

    Though the interim analysis found improvement in patients’ progression-free survival in the “intent-to-treat” population, similar results did not show up for overall survival. The interim analysis also found no safety concerns with regards to the treatment.

    “We are disappointed that the MARQUEE trial did not provide statistically significant results for overall survival in a disease and treatment setting which remains a major unmet medical need,” said Paolo Pucci, CEO of ArQule.

    Daiichi Sankyo’s global head of R&D stated that the companies will “continue to investigate tivantinib in other tumor types.”

    The cancelled trial has been seen as a huge blow by ArQule investors, and the Wall Street Journal reports that the company’s stock dropped 55% in light of the news, down to $2.15 at the close of Tuesday’s trading.

  • Cancer Treatment for Colorectal Cancer Approved

    The U.S. Food and Drug Administration (FDA) this week announced that it has approved a new drug for the treatment of colorectal cancer. According to the U.S. Centers for Disease Control and Prevention (CDC), colorectal cancer is the third most common cancer for both men and women, and the third leading cause of cancer deaths in the U.S.

    The drug will be marketed under the name Stivarga by Bayer HealthCare Pharmaceuticals. It is approved to treat patients that have already been treated for colorectal cancer, but seen the disease metastasize and spread to other parts of the body. The treatment is a multi-kinase inhibitor that blocks specific enzymes that promote cancer growth.

    “Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients’ lives and is the second drug approved for patients with colorectal cancer in the past two months,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research.

    Last month, a drug named Zaltrap was approved to treat adults with metastatic colorectal cancer.

    Stivarga was approved one month ahead of when the FDA was expected to complete its review of the drug. The treatment was fast-tracked by the FDA under its priority review program, which expedites a six-month review for drugs that are “major advances” in treatment.

    A study of 760 patients with metastatic colorectal cancer showed the effect of Stivarga. Studies showed that patients who received Stivarga saw a delay in tumor growth with a median of two months compared to those receiving a 1.7-month-median placebo. Overall, the patients treated with the drug lived a median of 6.4 months compared to placebo patients, who lived a median of five months.

  • New MS Treatment Shown to Reduce Relapses

    New MS Treatment Shown to Reduce Relapses

    Two phase 3 clinical trials have shown that oral doses of a drug called BG-12 show “significant” and “clinically meaningful” reductions in multiple sclerosis (MS) relapses and brain lesions in people with a relapsing form of MS.

    The active ingredient in BG-12 is the compound dimethyl fumarate. The trials, which were published yesterday in the New England Journal of Medicine, were financed by Biogne Idec, a biotechnology company that creates drugs for neurological and autoimmune disorders. The company is seeking U.S. Food and Drug Administration (FDA) approval for the treatment.

    “The publication of both dimethyl fumarate pivotal studies in NEJM is another achievement for this important investigational therapy,” said Dr. Katherine Dawson, senior medical director at Biogen Idec Neurology Research and Development and co-author of the published studies. “The data from its clinical development program consistently indicate that dimethyl fumarate may provide tangible benefits and address existing treatment needs of people living with MS. We are working closely with regulatory authorities across the globe with the aim of making the review of dimethyl fumarate as quick as possible.”

    The two studies found that both twice-a-day and thrice-a-day 240mg treatments with BG-12 reduced the proportion of patients with relapsing-remitting MS who relapsed by anywhere from 44% to 51%. Both studies were two-year global clinical trials that investigated BG-12 compared to a placebo.

    Just last week, a once-a-day pill for the treatment of relapsing forms of MS called Aubagio was approved by the FDA.

  • Multiple Sclerosis Pill Approved by U.S. FDA

    The U.S. FDA this week approved a once-a-day pill for the treatment of multiple sclerosis (MS). The pill, being branded as “Aubagio” by Sanofi S.A., is specifically for the treatment of adults with relapsing forms of MS.

    “In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo,” said Dr. Russell Katz, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.”

    According to the National Institutes of Health, MS is a chronic autoimmune disease that affects the central nervous system. It disrupts the communication between the brain and the body, causing motor skill disruption for nearly every part of the body, depending on which nerves in the brain are damaged.

    As for the drug itself, side effects seen during drug trials included diarrhea, abnormal liver tests, nausea, and hair loss. Also, the box warnings for the drug warn of possible liver problems and fetal harm, including the risk of birth defects. Doctors will have to check patient’s liver function and give a pregnancy test before starting treatment with Aubagio.

    “Many people living with MS struggle with the additional burden of injectable therapies administered daily to weekly,” said Dr. Aaron Miller, medical director at the center for multiple sclerosis at Mount Sinai Medical Center. “The FDA’s approval of Aubagio, a new oral treatment option, is an encouraging advancement for the MS community and may be a valuable treatment for people living with this often debilitating disease.”

  • Leukemia Drug Approved by the FDA

    Pfizer this week announced that Bosulif, a medication it developed for the treatment of a rare type of Leukemia, has been approved by the U.S. Food and Drug Administration.

    The medication is approved for the treatment of adults with chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myelogenous leukemia (CML) that has resisted prior therapy. The American Cancer Society estimates that almost 5,500 new CML cases will be diagnosed in 2012, and that just over 600 people will die of the disease. Just over 10% of new leukemia cases are CML, and over half of the people who get it are over the age of 65. According to Pfizer, Bosulif blocks CML cell growth by inhibiting the Abl and Src signaling pathways.

    “Bosulif is an important new addition to the CML treatment landscape,” said Dr. Jorge Cortes, professor of medicine in the Department of Leukemia at the University of Texas, and a lead investigator of the Pfizer’s registrational study for Bosulif. “Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors.”

    Bosulif was quickly approved because of its status as an orphan drug. Orphan drugs are drugs that have been developed to treat rare diseases and conditions. In the U.S. and E.U., orphan drugs are fast-tracked for approval, and companies can often charge a premium for them. The wildly expensive scorpion antivenom Anascorp is another example of a recently approved orphan drug.

  • HIV Treatment Approved by the FDA

    HIV Treatment Approved by the FDA

    Gilead Sciences, a biotech research company, announced today that its new HIV treatment drug has been approved by the U.S. Food and Drug Administration. Dubbed Stribild, the once-daily tablet is made up of four different compounds and designed for those not currently taking medication for HIV.

    “Over the past decade, co-formulated HIV medicines have simplified therapy for many patients and have become standard of care,” said Dr. Paul Sax, professor of medicine at Harvard Medical School, and principal investigator on a Stribild study. “Today’s approval of Stribild will provide physicians and their patients an effective new single tablet treatment option for individuals starting HIV therapy for the first time.”

    Stribild was approved following two studies that proved Stribild at least as effective as Atripla, another of Gilead’s single-tablet HIV regimin drugs which was approved by the FDA in 2006. Though Stribild does not cure HIV, it does block the ability for the HIV-1 virus to integrate into the genetic material of human cells. According to Gilead, the adverse side-effects of the medication, which include nausea, diarrhea, headache, fatigue, and abnormal dreams, were mild to moderate. The drug also includes box warnings for people with hepatitis B or those taking other antiretroviral drugs.

    “For much of the company’s 25-year history, Gilead has focused on the development of improved treatments and simplified regimens for HIV,” said John Martin, chairman and CEO of Gilead. “Therapies that address the individual needs of patients are critical to enhancing adherence and increasing the potential for treatment success, and we are proud to introduce a new single tablet regimen for the healthcare and patient communities.”

    Full prescribing information for Stribild can be found on Gilead’s website.

  • Lung Disease Drug Trials Point Toward Approval

    Lung Disease Drug Trials Point Toward Approval

    GlaxoSmithKline (GSK) this week announced that phase III of trials for its new long-acting muscarinic antagonist/long-acting beta2 agonist (LAMA/LABA) drug are complete. The drug, which is administered via inhaler, is a once-daily medicine for treatment of chronic obstructive pulmonary disease (COPD), one of the most common forms of lung disease. The trials involved around 6,000 patients with COPD. The medication was developed in association with Theravance, a biopharmaceutical research company.

    According to GSK, the LAMA/LABA being studied is a combination of two molecules – umeclidinium bromide (UMEC) and vilanterol. The UMEC is the experimental aspect of the medication that is currently being developed for the treatment of COPD. A 50-week safety study of UMEC and vilanterol has been completed, as well as two different 12-week crossover exercise studies.

    The trials appear to be a success, though the results of this study and others will be presented “at future scientific meetings.” Still, GSK stated that it intends to file for approval of the drug throughout its global markets.

    The UMEC and vilanterol LAMA/LABA is only one of a few respiratory drugs GSK is researching. It already has tradmarks on the brand names RELVAR and BREO for a fluticasone furoate/vilanterol drug, though it too is not yet approved anywhere. These drugs have the potential to become GSK’s next generation of respiratory treatment drugs. GSK currently markets Advair as a treatment for respiratory symptoms.

  • More Americans Accessing Internet And Social Media For Medical Advice

    More Americans Accessing Internet And Social Media For Medical Advice

    Americans looking for medical advice are visiting medical websites, social media sites, and online communities in greater numbers than the websites of pharmaceutical companies, according to a new survey from Accenture.

    More than two-thirds (68%) of Americans go online for health information, and just 11 percent access a pharmaceutical company’s website to find information about a medical condition compared the the majority (92%) who access other online resources more frequently.

    “Pharmaceutical companies that embrace innovations such as social networking and communications via mobile devices and integrate and align their communication strategy across multiple channels will be positioned to have a much greater influence on their patients’ choices and consequently, realize significant increases in revenue, profitability and sustained competitive advantage,” said Tom Schwenger, global managing director for Accenture’s Life Sciences Sales & Marketing practice. 

    Accenture According to the survey, 69 percent of respondents expect pharmaceutical companies to provide information about the medical condition or illness for which they are taking drugs. To address that expectation, Accenture believes pharmaceutical companies must not only provide the right information, but upgrade their websites to create a more dynamic, interactive experience.

    “The survey results clearly show that pharmaceutical companies must adopt a better understanding of their patient behavior through sophisticated analysis in order to fully capitalize on how patients interact with social media channels and websites,” said Schwenger.

    “With only 11 percent of survey respondents saying they most often use a pharmaceutical company’s web site to seek information about an illness or condition when looking online, pharmaceutical companies have a tremendous opportunity to better connect with patients through multiple digital venues in addition to their own website.”