FDA and EMA accept supplementary filings for ofatumumab in RMS

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab (OMB157) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults, submitted by Swiss pharma giant Novartis (NOVN: VX).

The company expects regulatory approval for ofatumumab in the USA in June 2020 and in Europe by the second quarter of 2021. Novartis’ shares were down 2.9% at 91.66 by early afternoon trading today, in an overall Swiss market that was down 3.2% and amid a major global sell-off as the number of coronavirus cases increases outside of China.

Ofatumumab already has an approval for chronic lymphocytic leukemia and is marketed under the trade name Arzerra, but Novartis sees it as a potential blockbuster in multiple sclerosis. Novartis obtained rights for ofatumumab from Danish biotech company Genmab (Nasdaq: GEN) in all indications, including MS, in December 2015. In January 2018, Novartis and Genmab stopped marketing Arzerra outside the USA, citing a lack of market traction due to competition in its currently-approved indication.