Gilenya Approved for Relapsing MS
WEDNESDAY, Sept. 22 -- Gilenya (fingolimod) has been approved by the U.S. Food and Drug Administration to reduce relapses and delay disability progression in people with relapsing forms of multiple sclerosis.
The drug is among a new class of medications designed to block certain blood cells in lymph nodes, delaying the cells' travel to the brain and spinal cord, the agency said in a news release.
Multiple sclerosis (MS) is a chronic, disabling nervous system disease that affects some 400,000 people in the United States and 2.1 million globally, the FDA said. Symptoms can range from mild limb numbness to severe problems such as paralysis or impaired vision.
Gilenya could have serious side effects including a decrease in heart rate shortly after the drug is started, the FDA said. Other adverse reactions could include a greater risk of infection, and macular edema of the eye. Patients who take the drug should be carefully monitored for these conditions.
The drug's most frequently reported side effects include headache, flu, diarrhea, back pain, cough and elevated enzymes of the liver, the agency said.
Gilenya is made by Novartis, based in Basel, Switzerland.
To learn more about MS, visit the U.S. National Institute of Neurological Disorders and Stroke.
Posted: September 2010