GMAB - Genmab's Kesimpta OK'd in Europe for multiple sclerosis

Genmab (GMAB) announces that the European Commission ((EC)) has granted Novartis (NVS) marketing authorization for the use of Kesimpta (ofatumumab) in the treatment of relapsing forms of multiple sclerosis ((RMS)) in adults. The approval 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 EC approval follows a positive opinion issued for subcutaneous ofatumumab in RMS by the advisory committee of the EMA in January 2021.

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Genmab's Kesimpta OK'd in Europe for multiple sclerosis