Genmab A/S (GMAB) Announces FDA Extension of sBLA Review, Submitted by Novartis (NVS), for Ofatumumab in Relapsing Multiple Sclerosis
Genmab A/S (NASDAQ: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has notified Novartis (NYSE: NVS) that the agency has extended its review of the supplemental Biologics License Application (sBLA) for subcutaneous ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults. Regulatory action in the U.S. is now anticipated in September 2020. Ofatumumab is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG.
“As our partner Novartis works with the U.S. FDA to continue the review for subcutaneous ofatumumab in relapsing multiple sclerosis, we continue to look forward to its potential approval in the U.S., as well as in other territories where regulatory filings are underway,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About Ofatumumab
Ofatumumab (OMB157) is a fully human CD20 monoclonal antibody (mAb) self-administered by a once-monthly subcutaneous injection that is in development for relapsing MS. Ofatumumab works by binding to the CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion. Positive Phase IIb results in MS patients were presented in 2014 and showed a marked significant reduction in the number of new brain lesions in the first 24 weeks after ofatumumab administration. Novartis initiated a Phase III program for ofatumumab in RMS in August 2016. Ofatumumab is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG.