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FDA Approves Gilenya (Fingolimod-FTY720) – First Oral Disease-Modifying Therapy for Relapsing MS – Expected to be

Posted Sep 24 2010 12:00am
Sep 22, 2010
The U.S. Food and Drug Administration has approved fingolimod capsules (Gilenya,™ Novartis International AG) for reducing the frequency of clinical relapses and delaying the accumulation of physical disability in 
relapsing forms
 of MS, making it the first oral disease-modifying therapy for the treatment of multiple sclerosis. According to Novartis, the drug will be available for prescription in coming weeks.
Gilenya (pronounced Jil-EN-ee-ah) will be available as a first-line treatment, which means that there are no recommendations in the approved labeling for people to try other MS therapies before taking Gilenya.
In June 2010, the National MS Society was among individuals and patient advocacy groups that provided public testimony at an FDA advisory committee meeting about the unmet need for more therapies for people with MS.
Comment:“The FDA’s approval of the first oral disease modifying therapy is a significant step for people with MS, and helps address the unmet need for additional therapies,” said National MS Society Chief Medical Officer Aaron Miller, MD, Professor of Neurology and Medical Director of the MS Center at Mount Sinai Medical Center in New York City. Robert Lisak, MD, Chair of Neurology and Professor of Immunology and Microbiology at Wayne State University School of Medicine in Detroit, agreed. “I welcome having another treatment option for my patients, particularly an oral medication that might make it easier for people to get on and stay on therapy. Taking a disease-modifying therapy is the best way we have of reducing MS disease activity and future deterioration. However, we will need to monitor all new therapies for any long-term safety issues.”About Gilenya: Fingolimod is a new class of therapy for treating multiple sclerosis. It binds to a docking site (sphingosine-1-phosphate receptor, or S1P receptor) on immune cells, including T cells and B cells, which have been implicated in causing nervous system damage in MS. The drug appears to induce some immune cells to remain in lymph nodes, inhibiting them from migrating into the brain and spinal cord.Potential Benefits and Risks: Positive results from two large-scale phase III clinical trials have been published showing that fingolimod significantly reduced multiple sclerosis relapse rates and reduced disease activity as measured by MRI. In the one-year trial comparing fingolimod to interferon beta-1a (Avonex®, Biogen Idec), fingolimod was found to have a greater impact on relapse rates and on MRI. In the two-year trial, fingolimod delayed the progression of physical disability compared to placebo. (New EnglandJournal of Medicine January 20, 2010.)  Read more  about these studies on our Website.The most common adverse reactions listed in Gilenya’s  prescribing information  are headache, flu, diarrhea, back pain, liver enzyme elevations and cough.The label carries warnings about other potentially serious risks, including decreased heart rate and/or other heart effects after the first dose; the potential for increased risk of infections (in clinical trials, a small number of serious herpes infections occurred, including two deaths from herpes infections that occurred in people taking a dose higher than the approved dose of Gilenya); risk of macular edema (swelling of the center of the retina inside the eye); decrease in lung function; slight increase in blood pressure; increases of liver enzymes (which could indicate liver injury), and risk of harm to fetus (Category C, based on animal studies).   The long-term safety of Gilenya is unknown at this time. Other phase III clinical trials of Gilenya, including one involving people with primary progressive MS, are still under way, as are extension studies involving those who have completed trials. These and other post-marketing studies should provide additional data on the safety and efficacy of Gilenya.CONTINUE to READ Information on this new medication, by clicking here

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