FDA extends PDUFA review date for subcutaneous ofatumumab for the treatment of relapsing forms of multiple sclerosis to September 2020.-Novartis.

Genmab A/S announced that the FDA has notified Novartis 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 in lieu of 30 June 2020.

Ofatumumab is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG.