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FDA and EMA accept filings of subcutaneous ofatumumab for the treatment of relapsing Multiple Sclerosis.- Genmab A/S + Novartis

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Published:25th Feb 2020
Genmab A/S announced that the FDA has accepted, with priority review, the supplemental Biologics License Application (sBLA) submitted by Novartis for subcutaneous ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults. Novartis anticipates potential regulatory approval in the U.S. in June 2020. In addition to the sBLA in the U.S., Novartis submitted a Marketing Authorization Application for approval of subcutaneous ofatumumab in RMS to the European Medicines Agency (EMA), which was also recently accepted for review, with potential approval expected by the second quarter of 2021. Ofatumumab is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG. The regulatory submissions were based on data from the Phase III 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 results from these studies were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September 2019.
Condition: Multiple Sclerosis
Type: drug

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