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news.Novartis' oral multiple sclerosis (MS) treatment Gilenya (fingolimod) 0.5mg daily, a first-line treatment for relapsing forms of multiple sclerosis, has received approval from the US Food and Drug Administration (FDA).
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Novartis claimed that the FDA approval makes Gilenya the first oral treatment indicated for relapsing forms of MS available in the US.
Gilenya belongs to a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators.
Novartis said that Gilenya reduces the frequency of MS relapses (flare-ups) and helps slow the build-up of some of the physical problems caused by MS.
National Multiple Sclerosis Society Healthcare Delivery and Policy Research vice president Nicholas LaRocca said that a new treatment option that offers efficacy in the convenience of a capsule is a welcome alternative to frequent injections for individuals living with that disease.
Novartis’ Gilenya approval was based on the largest clinical trial program ever submitted to date to the FDA for a new MS drug and included combined data from clinical studies showing efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI), a measure of disease activity, in people with relapsing forms of MS.
Novartis Pharma Global Head of Development Trevor Mundel said that they were proud to have worked successfully with the MS community toward a shared goal of bringing a new efficacious treatment to people with relapsing forms of MS and that they were actively pursuing regulatory approval in Europe and the rest of the world.