FDA extends review of supplemental biologics license application for ofatumumab for relapsing multiple sclerosis by three months

Submission for this targeted B-cell therapy was based on results from phase III ASCLEPIOS I and II trials comparing ofatumumab with teriflunomide, which met their primary endpoints, demonstrating a significant decrease in the number of confirmed relapses.

SPS commentary:

Ofatumumab is intended to be self-administered at home through an autoinjector pen and was filed for approval in EU in February 2020.

Biospace Inc.