GMAB - Genmab's ofatumumab wins positive recommendation from CHMP

Genmab A/S ([[GMAB]] -1.5%) gets positive recommendation for marketing approval for its subcutaneous ofatumumab for the treatment of relapsing forms of multiple sclerosis in certain adults from the Committee for Medicinal Products for Human Use ((CHMP)).Ofatumumab is being developed and marketed worldwide by Novartis ([[NVS]] -3.2%) under a license agreement with Genmab. Novartis submitted the Marketing Authorization Application for ofatumumab in this indication in January 2020.The opinion from the CHMP of the European Medicines Agency ((EMA)) was based on data from the Phase 3 ASCLEPIOS I and II trials, which investigated the efficacy and safety of monthly subcutaneous ofatumumab 20mg versus once daily oral teriflunomide 14mg in adults with RMS.The positive update comes weeks after Genmab won FDA approval for its DARZALEX FASPRO to treat newly diagnosed Light-chain ((AL)) amyloidosis, a rare disease affecting an estimated ~3,000 to 4,000 individuals in the U.S. annually.

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Genmab's ofatumumab wins positive recommendation from CHMP