Gilenya Approved for Relapsing MS09/22/10
WEDNESDAY, Sept. 22 (HealthDay News) -- 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
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
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