The Food and Drug Administration approved Novartis’ Gilenya “to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis.”
The medication is the first oral MS drug that is available in capsules rather than through injections or intervenes infusions. The FDA said the medication, also known by its chemical name fingolimod, is the first of a new class of MS 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,” according to the FDA.
The FDA noted that the medication also has side effects. Patient can experience a decrease in heart rate when they start taking the drug. Gilenya can also increase the risk of infections and macular edema, a serious eye problem. The more common side effects reported during clinical trials of the drug were headaches, diarrhea, back pain, and the elevation of certain liver enzymes.
“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, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
In it’s release on the drug Novartis noted that Gilenya had a “studied safety and tolerability profile, which has been characterized in over 2,600 clinical trial patients, some of whom are in their seventh year of treatment, with more than 4,500 patient years of experience.”
Trevor Mundel, global head of development at Novartis Pharma AG said that the company is seeking regulatory approval for the medication in Europe and elsewhere.
“Today is a significant and encouraging day for people with relapsing forms of MS in the US,” said Nicholas LaRocca, vice president of healthcare delivery and policy research at the National Multiple Sclerosis Society, in a statement release by Novartis. “A new treatment option that offers significant efficacy in the convenience of a capsule is a welcome alternative to frequent injections for individuals living with this chronic disease.”
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