FDA Delays Ruling on Novartis’ Relapsing Multiple Sclerosis Drug

Novartis will have to wait a little longer to see if the U.S. Food and Drug Administration (FDA) will greenlight Arzerra (ofatumumab) as a treatment for patients with relapsing multiple sclerosis (RMS).

On Tuesday, the FDA extended its review of the Supplemental Biologics License Application for Arzerra in this indication by three months. Regulatory action is now expected in September 2020, the company said. Novartis did not disclose any reason for the regulatory delay in its announcement.