Fingolimod, a drug manufactured by Novartis under the brand name Gilenya, is a U.S. Food and Drug Administration (FDA)-approved treatment for symptoms of relapsing forms of multiple sclerosis (MS). It is immunomodulatory in nature, and works to reduce MS exacerbations and so delay progression toward disability.

How Gilenya Works

Fingolimod is a modulator of the sphingosine 1-phosphate receptor (S1P family of receptors). This receptor is involved in cell proliferation, maturation, angiogenesis and chemotaxis, and the entire S1P family of receptors are involved in suppression of innate immune responses from T-cells. Fingolimod helps to modulate these receptors in such a way so as to retain the lymphocytes (immune cells) within the lymph nodes, preventing them from crossing the blood-brain barrier, reducing inflammatory damage caused to the central nervous system.

History of Gilenya

The Phase 3 clinical trials FREEDOMS (NCT00289978), FREEDOMS II (NCT00355134) and TRANSFORMS (NCT00340834), demonstrated that Gilenya significantly decreased the risk of worsening disability and reduced relapse rate compared to a placebo and Avonex (another MS treatment). Extension trials have shown that this can be maintained for at least seven years.

After observing its safety and efficacy in patients through extensive clinical trials, the FDA approved therapeutic use of the drug in September 2010, making it the first oral formulation approved for relapsing and remitting forms of MS. In March 2011, Novartis Pharmaceuticals announced receipt of a compliance notice from Health Canada to commercialize the drug, and the European Medicines Agency approved the drug that same month.

Other Gilenya Details

According to Novartis and the FDA, the normal recommended dosage for Gilenya is 0.5mg/day, with or without food. Prescription of the drug has to be scrutinized by medical experts due to previous cases of macular edema, hemorrhaging focal encephalitis (an inflammation of the brain with bleeding), progressive multifocal leukoencephalopathy, and varicella zoster infections being reported in some patients. Common side effects associated with Gilenya include dizziness, headaches, nausea, and fatigue. Since the drug is immunomodulatory, patients with infectious diseases should avoid using it, as these infections may worsen as a result of a temporarily less active immune system.

Recent findings have indicated a slow heart rate, breathing problems, and liver problems in MS patients taking the drug, and heart rate monitoring is recommended upon treatment initiation. Anyone who has a recent (within the past six months) incident of bradycardia, mild to moderate angina, transient ischemic attack, or has undergone heart surgery also should have an electrocardiogram, ECG or EKG, conducted by the expert, before being prescribed the drug. The FDA in May 2012 announced that Gilenya is contraindicated in patients with certain pre-existing or recent heart conditions or stroke, or who are taking certain antiarrhythmic medications. Pregnant women are also advised not to take Gilenya.

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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