The U.S. Food and Drug Administration has approved Gilenya capsules to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS), a disorder usually treated with injections and infusions.
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 FDAs Center for Drug Evaluation and Research.
Gilenya, made by Novartis AG, 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.
The drug has also been approved in Russia and is awaiting approval in other countries. Merck is now selling a similar MS drug, cladribine, in Australia and Russia and is expecting approval in the U.S. later this year.
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.
Read more about Multiple Sclerosis.
