1. Aug 24, 2020

FDA approves ofatumumab for relapsing multiple sclerosis

The U.S. Food and Drug Administration has approved ofatumumab (Kesimpta; Novartis) injection for subcutaneous use for the treatment of patients with relapsing multiple sclerosis, according to a press release.

Ofatumumab is the only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis.

Approval is based on results from the Phase III ASCLEPIOS I and II studies. In the studies, ofatumumab showed superiority versus teriflunomide in significantly reducing the annualized relapse rate, 3-month confirmed disability progression, and the number of gadolinium-enhancing T1 and new or enlarging T2 lesions.

“This approval is wonderful news for patients with relapsing multiple sclerosis. In the key clinical studies, this breakthrough treatment produced a profound reduction in new brain lesions, reducing relapses and slowing underlying disease progression1,” said Professor Stephen L. Hauser, Director of the UCSF Weill Institute for Neurosciences and co-chair of the steering committee for the ASCLEPIOS I and II studies, in a press release. “Through its favorable safety profile and well-tolerated monthly injection regimen, patients can self-administer the treatment at home, avoiding visits to the infusion center.”

Read the full press release here.