Excerpt
The FDA has approved fingolimod (Gilenya), the first oral drug for multiple sclerosis to reach the market.
Its label states that the drug may "reduce relapses and delay disability progression in patients with relapsing forms" of MS, according to an FDA announcement.
An FDA advisory committee voted unanimously in June to recommend the approval of the drug, which will be available in 0.5-mg capsules.
Fingolimod inhibits migration of T cells out of lymph nodes, essentially bottling them up to prevent them from attacking the protective myelin sheaths surrounding nerve fibers. Specifically, the drug causes the sphingosine-1-phosphatase receptor, which normally sits on the surface of T and B cells, to withdraw into the cell interior.
All other approved treatments for MS -- interferon-beta, glatiramer acetate (Copaxone), and natalizumab (Tysabri) -- are injection drugs. Patients and clinicians have voiced a desire for orally available alternatives.
"The FDA's approval of the first oral disease modifying therapy is a significant step for people with MS, and helps address the unmet need for additional therapies," according to Aaron Miller, MD, of Mt. Sinai Medical Center in New York City, in a statement provided by the National MS Society.
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