FDA approves generic fingolimod

Gilenya, or Fingolimod, is the first approved oral disease modifying drug for MS.
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FDA approves generic fingolimod

Post by NHE » Tue Jun 30, 2020 8:35 am

FDA Approves Generic Versions of Gilenya
December 6, 2019


On December 5, 2019, the United States Food and Drug Administration (FDA) announced that they had approved the applications from three separate pharmaceutical companies for the first generic versions of Gilenya® (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. Approved in September 2010, Gilenya was the first oral drug available for the long-term treatment of relapsing-remitting MS.

Generic treatments carry the same benefits and risks of the initially approved medication. While this medication has been shown to slow disease activity, such as reducing the frequency of relapses as well as reducing the number of lesions as shown on magnetic resonance imaging (MRI), Gilenya’s potential side effects and adverse events include a temporary slowing of the heart rate, edema (swelling) behind the eye, and liver changes. Usually occurring in patients with weakened immune systems, progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that could potentially occur. Along with some of the other long-term treatments for MS, PML has been reported in a small number of individuals taking Gilenya.

The three pharmaceutical companies who received this approval of their generic Gilenya are HEC Pharm Co. Limited, Biocon Limited, and Sun Pharmaceutical Industries Limited. Further details on how soon these companies may market their generic versions of Gilenya and when these will be available to the MS community have not yet been announced. MSAA will update this information as soon as it becomes available.

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