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Novartis AG Gets First U.S. Approval for MS Drug Gilenya; Novartis Ahead of Merck KGaA (MKGAF.PK) in Race to Get to Market


9/22/2010 6:51:02 AM

SILVER SPRING, Md., Sept. 22 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO )

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )

"Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.

Gilenya is the first in a new class of drugs that block some blood cells in lymph nodes, reducing their migration to the brain and spinal cord, which may help with reducing the severity of MS.

MS is a chronic, often disabling, disease that affects the central nervous systemthe brain, spinal cord, and optic nerves. According to the National Multiple Sclerosis Society, there are about 400,000 people in the United States and 2.1 million people worldwide with MS.

The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. Symptoms can be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision.

Patients using Gilenya should be monitored for a decrease in heart rate upon starting the drug. Gilenya may also increase the risk of infections. Cases of serious eye problems (macular edema) have occurred in patients taking the drug and an ophthalmologic evaluation is recommended.

The most frequent adverse reactions reported by patients taking Gilenya in clinical trials include headache, influenza, diarrhea, back pain, elevation of certain liver enzymes and cough.

The drug will be available in 0.5 milligram capsules. Gilenya is made by Novartis, Basel, Switzerland.

For more information:

National Institute of Neurological Disorders and Stroke: Multiple Sclerosis Information

http://www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm

Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration




   

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