Posted by Michael Wonder on 02 Jun 2020
Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
2 June 2020 - Novartis today announced that it has received notice from the US FDA that the agency has extended its review of the supplemental biologics license application for ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis.
Regulatory action is now expected in September 2020.
Additional regulatory filings are currently underway and regulatory approval for ofatumumab in Europe is expected by Q2 2021.
