Gilenya: FDA has approved first oral drug to reduce multiple sclerosis relapses


The FDA ( Food and Drug Administration ) has approved Gilenya capsules ( Fingolimod ) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis.

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 multiple sclerosis.

Multiple sclerosis is a chronic, often disabling, disease that affects the central nervous system ( 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 multiple sclerosis.

The progress, severity, and specific symptoms of multiple sclerosis 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.

Source: FDA, 2010

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