BRIEF—FDA extends review of ofatumumab sBLA review in MS

The US Food and Drug Administration (FDA) has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), Novartis’ self-administered, targeted B-cell therapy for relapsing multiple sclerosis.

A decision is now due from the regulator by September 2020 and, should it be approved, the Swiss drugmaker has said that it is prepared and ready for a swift launch.

Novartis has said that additional regulatory filings are currently underway and regulatory approval for ofatumumab in Europe is expected by the second quarter of 2021.