FDA approves first oral drug that reduces multiple sclerosis relapses

September 22nd, 2010 - 9:52 pm ICT by BNO News  

SILVER SPRING, MARYLAND (BNO NEWS) — The U.S. Food and Drug Administration (FDA) on Wednesday announced that it has approved the first oral drug to reduce multiple sclerosis (MS) relapses.

Gilenya capsules (fingolimod) are 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 relapses and delay disability progression in patients with relapsing forms of MS.

“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.

However, patients using Gilenya should be monitored for a decrease in heart rate upon starting treatment. They should also be aware that 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.

MS is a chronic, often disabling, disease that affects the central nervous system—the 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.

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