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Novartis: FDA, EMA To Review Filings For Ofatumumab - Quick Facts

Novartis (NVS) announced the US FDA and European Medicines Agency have accepted the company's Supplemental Biologics License Application (sBLA) and Marketing Authorization Application for ofatumumab, a B-cell therapy, for the treatment of relapsing forms of multiple sclerosis in adults. The company expects regulatory approval for ofatumumab in the US in June 2020 and in Europe by the second quarter of 2021.

Novartis noted that, if approved, ofatumumab has the potential to become a first-choice treatment for a broad RMS population and the first B-cell therapy that is easy to start and manage in a monthly subcutaneous injection that can be self-administered at home using an autoinjector pen.

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