Category Archives: MS Treatment

Public release date: 13-Sep-2012 [ | E-mail | Share ] Contact: Todd Murphy murphyt@ohsu.edu 503-494-8231 Oregon Health & Science University PORTLAND, Ore. Many people with multiple sclerosis for years have taken the natural supplement Gingko biloba, believing it helps them with cognitive problems associated with the disease. But the science now says otherwise. A new study published in the journal Neurology says Gingko biloba does not improve cognitive performance in people with multiple sclerosis. The research was published in the Sept. 5, 2012, issue of Neurology, the medical journal of the American Academy of Neurology. The current study was a more extensive look at the question after a smaller 2005 pilot study suggested there might have been some cognitive benefits in MS patients using the supplement. That study found that Gingko seemed to improve attention in MS patients with cognitive impairment. But the larger follow-up study, conducted with patients at the Portland and Seattle Veterans Affairs medical centers, found no cognitive benefits to using Gingko. "It's important for scientists to continue to analyze what might help people with cognitive issues relating to their MS," said Jesus Lovera, M.D, the study's lead author, a former fellow at the Portland VA Medical … Continue reading →

Genzyme, a subsidiary of Sanofi (SNY), announced Wednesday night that the FDA has approved Aubagio, its oral, once-daily treatment for Relapsing Remitting Multiple Sclerosis (RRMS). Aubagio is only the second oral treatment to hit the market, following Novartis` (NVS) Gilenya in 2010, although Teva (TEVA) and Biogen Idec (BIIB) are developing oral treatment options as well. Sanofi acquired Aubagio when the company purchased Genzyme for more than $20B in 2011. While the approval news from Sanofi is positive for the company, analysts are questioning Aubagio`s potential in the market as other injectable drugs (Rebif for instance) and upcoming compounds have shown better efficacy, and Biogen`s BG-12, widely thought to be the next big MS treatment, is set for approval later this year. Aubagio`s oral formulation will be a strong selling point, and recent FDA safety concerns with Gilenya should improve sales as well, but a variety of MS treatments in development may overshadow the new drug. As mentioned, BG-12 is undergoing regulatory review for approval, and has demonstrated strong results as an oral MS treatment. Genzyme, however, believes that Aubagio`s opportunity will be as a complement to its development-stage injectable, Lemtrada. Lemtrada, which was delayed by the FDA earlier this … Continue reading →

Sanofi (SNY) and its subsidiary Genzyme recently announced that their oral candidate for relapsing forms of multiple sclerosis (:RMS), Aubagio (teriflunomide), has received US Food and Drug Administration (:FDA) approval. The FDA approved Aubagio as a once-daily treatment for patients with RMS. Aubagio is currently under regulatory review in the EU. FDA approval came in on encouraging data from a pivotal phase III study (:TEMSO) in patients with RMS. The TEMSO phase III study evaluated Aubagio in two dosage strengths, 7mg and 14mg. Patients in both 7mg and 14mg Aubagio dosage arms demonstrated a 31% reduction in annualized relapse rate compared to placebo. Additionally, the company presented positive results from the phase III TOWER trial, which was conducted on 1,169 patients with RMS. However, we note that in the TENERE trial, reported in December 2011, Aubagio failed to show statistical superiority over Pfizer/Merck KGaAs (PFE/MKGAF) Rebif. There are two more studies in progress, namely TOPIC and TERACLES. Competition in the oral multiple sclerosis market will be intense and Aubagio needs to demonstrate superior efficacy and tolerability to gain share. Novartis (NVS) Gilenya already has a lead in the oral MS market with the product being approved in September 2010. Another … Continue reading →

By Jennifer Corbett Dooren WASHINGTON--The Food and Drug Administration on Wednesday approved a Sanofi SA pill to treat multiple sclerosis, making it the second oral therapy for the disease to be available on the U.S. market. Competition has steadily grown over the last decade in the multibillion-dollar-a-year market for treating multiple sclerosis, whose sufferers include Ann Romney, wife of Republican presidential candidate Mitt Romney. Novartis AG brought the first oral pill for treating multiple sclerosis onto the U.S. market in 2010. The pill, Gilenya, recorded world-wide sales of $530 million in the first half of 2012, according to Novartis. Sanofi's new drug, teriflunomide, will be sold under the brand name Aubagio to treat people with the relapsing remitting form of MS. Multiple sclerosis is a progressive disease that involves damage to nerves controlling muscles and vision. It affects about 400,000 Americans and 2.5 million people world-wide. The condition causes the body's immune system to eat away at the protective covering of the nerves, or myelin, which disrupts the electrical signals between the brain and the rest of the body. Most MS patients are of the relapsing- remitting type, where the disease flares up periodically and largely disappears for long periods. … Continue reading →

(RTTNews.com) - The U.S. Food and Drug Administration Wednesday approved Sanofi's (SNY) multiple sclerosis drug Aubagio as a once daily tablet for the treatment of adults with relapsing forms of the disease. In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo. The drug contains a Boxed Warning to the risk of liver problems, including death, and a risk of birth defects. Physicians should do blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment. Also included in the Boxed Warning is an alert noting that the drug may cause fetal harm. The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair loss. Multiple Sclerosis, or MS, is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by … Continue reading →

By Jennifer Corbett Dooren WASHINGTON--The U.S. Food and Drug Administration Wednesday approved a Sanofi SA (SNY, SAN.FR) pill to treat multiple sclerosis, making it the second oral therapy that will be available on the U.S. market. The drug, teriflunomide, will be sold with the brand name Aubagio to treat people with the relapsing remitting form of MS. Multiple sclerosis is a progressive disease that involves damage to nerves controlling muscles and vision; it affects about 400,000 Americans and 2.5 million people world-wide. The condition causes the body's immune system to eat away at the protective covering of the nerves, or myelin, which disrupts the electrical signals between the brain and the rest of the body. Most MS patients are of the "relapsing- remitting" type, where the disease flares up periodically and largely disappears for long periods of time. Aubagio will compete with Novartis AG's (NVS) oral pill Gilenya, which was approved by the FDA in 2010 and has been available in Europe since 2011. FDA said a clinical trial showed the relapse rate for patients using Aubagio was about 30% lower than the rate for those taking a placebo, or sugar pill. The product was approved with FDA's strictest boxed … Continue reading →

FDA NEWS RELEASE For Immediate Release: Sept. 12, 2012 Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA approves new multiple sclerosis treatment Aubagio The U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (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 Russell Katz, M.D., director of the Division of Neurology Products in the FDAs 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. MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline. The most common side effects of Aubagio … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved AUBAGIO (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). AUBAGIO has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI. We are very excited to introduce AUBAGIO as a new treatment option that can make a difference in the lives of people with multiple sclerosis, said David Meeker, President and CEO, Genzyme. The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community. The FDA approval was based on efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. In the Phase III TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with relapsing forms of multiple sclerosis. AUBAGIO 7 mg significantly reduced the annualized relapse rate (p=0.0002) in the trial. Many people living … Continue reading →

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tcelna, a novel T-cell therapy for multiple sclerosis (MS), today announced the initiation of a Phase IIb clinical trial of Tcelna in patients with Secondary Progressive Multiple Sclerosis (SPMS). Several patients have already been enrolled in the study and enrollment is expected to increase rapidly as additional sites begin screening and enrolling patients in the coming weeks. Tcelna is the first ever personalized T-cell therapy for MS patients and has received Fast Track Designation from the United States Food and Drug Administration (FDA) for the treatment of SPMS. The therapy is specifically tailored to each patients individual disease profile and has demonstrated superior safety and encouraging indications of efficacy in previous clinical studies in MS that included the treatment of SPMS patients. There is currently only one FDA-approved treatment for SPMS but safety warnings have severely restricted its use. While a positive trial outcome will certainly be good news for SPMS patients, it is also not difficult to envision that it could position Tcelna as a promising treatment for the larger RRMS patient population as well. The newly initiated trial, named Abili-T, is a randomized, double-blind, placebo-controlled clinical study in … Continue reading →

The Universitys Brain Health Institute is expanding research on the treatment of brain disorders thanks to Cheryl Dreyfus, a leading multiple sclerosis researcher. Dreyfus, professor and chair of the Department of Neuroscience and Cell Biology at Robert Wood Johnson Medical School, said since she began working on models of the disease in tissue cultures, she hoped to approach a treatment for the autoimmune disease that affects about 350,000 people in the United States. We really dont know well what MS is, but were finding growth factors that affect cells in development can also affect those cells that are dying in MS [patients], she said. Dreyfus said her lab team is examining a protein called brain-derived neurotrophic factor (BDNF), which can help create new brain cells and prevent existing ones from dying. In patients with MS, the myelin sheath, or protective covering that insulates brain cells, disintegrates, Dreyfus said, leading to symptoms ranging from muscle spasms and difficulty speaking to visual impairment and depression. Many treatments for MS deal with treating inflammation that occurs when the sheath around the brain cells diminishes, Dreyfus said. But her labs approach to finding a treatment focuses on recovering brain function, she said. Her partnership … Continue reading →