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CHMP Issues Positive Opinion Recommending Ofatumumab in Relapsing Multiple Sclerosis
Genmab A/SJanuary 29, 2021 GMT
Company Announcement
Novartis receives positive CHMP opinion for subcutaneous ofatumumab for adult patients with relapsing forms of multiple sclerosis
Opinion based on Phase 3 ASCLEPIOS I and II studies
Copenhagen, Denmark; January 28, 2021 – Genmab A/S (Nasdaq: GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization of subcutaneous ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. Novartis submitted the Marketing Authorization Application for ofatumumab in this indication in January 2020. Ofatumumab is being developed and marke