EMA Panel Backs Generic for MS Drug Fingolimod (Gilenya)

Megan Brooks

May 01, 2020

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a generic version of fingolimod (Gilenya, Novartis) for highly active relapsing-remitting multiple sclerosis (MS).

The product, Fingolimod Accord (Accord Healthcare), will available as 0.5 mg capsules.

Fingolimod was first approved in Europe in 2011. Studies have demonstrated the satisfactory quality of Fingolimod Accord and its bioequivalence to the reference product Gilenya," the EMA said in a statement.

Fingolimod Accord is indicated for adults and children aged 10 years and older (with a body weight of >40 kg [88 lb]) who have highly active disease despite a "full and adequate" course of treatment with at least one disease-modifying therapy or patients with rapidly evolving severe relapsing remitting MS defined by two or more disabling relapses in 1 year, and with one or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared with a previous recent MRI.

Fingolimod acts as a superagonist to sphingosine-1-phosphate receptors on the surface of thymocytes and lymphocytes, reducing the overall number of circulating lymphocytes available to mount an autoimmune reaction to the myelin sheath surrounding axons in patients with MS.

Last year, the US Food and Drug Administration (FDA) approved three applications for first generic versions of fingolimod for adults with relapsing MS, as reported by Medscape Medical News.

Detailed recommendations for the use of Fingolimod Accord will be described in the summary of product characteristics, which will be made available in all official European Union languages following marketing authorization by the European Commission.

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