Novartis’ Gilenya Fails to Ameliorate Severe Form of Multiple Sclerosis

Gilenya, a sphingosine 1-phosphate receptor modulator also known as fingolimod, was the first FDA-approved oral disease modifying therapy for relapsing forms of multiple sclerosis (MS) upon approval in September 2010. Novartis’ drug is also under development as a candidate ALS therapy in partnership with ALSTDI. Now Novartis has announced that the drug failed to improve disability measures in a more rare form of MS called primary progressive multiple sclerosis (PPMS). The severe and irreversible central nervous system damage cause by PPMS is thought to be mediated by distinct pathways from the relapsing forms of MS, and the divergent drug effects of Gilenya between these two indications further support this hypothesis.

Gilenya, a sphingosine 1-phosphate receptor modulator also known as fingolimod, was the first FDA-approved oral disease modifying therapy for relapsing forms of multiple sclerosis (MS) upon approval in September 2010. Novartis’ drug is also under development as a candidate ALS therapy in partnership with ALSTDI. Now Novartis has announced that the drug failed to improve disability measures in a more rare form of MS called primary progressive multiple sclerosis (PPMS). The severe and irreversible central nervous system damage cause by PPMS is thought to be mediated by distinct pathways from the relapsing forms of MS, and the divergent drug effects of Gilenya between these two indications further support this hypothesis.

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