The first self-administered, targeted B-cell treatment for relapsing multiple sclerosis (MS) received FDA approval on Thursday, Novartis announced.
Ofatumumab (Kesimpta), an antibody targeting CD20-positive B cells, is approved for adult patients with clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, the company said.
“This approval is wonderful news for patients with relapsing multiple sclerosis,” Stephen Hauser, MD, of the University of California San Francisco, who led ofatumumab clinical trials, said in a statement from the drugmaker. “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.”
Like ocrelizumab (Ocrevus), which was approved in 2017 for relapsing and primary progressive MS, and rituximab (Rituxan), which is used off-label in MS, ofatumumab binds to CD20 molecules, resulting in B-cell depletion. In 2009, ofatumumab was approved to treat chronic lymphocytic leukemia under the brand name Arzerra.
Ofatumumab’s approval in MS was based on results of two phase III trials, ASCLEPIOS I and ASCLEPIOS II. In these studies, 20-mg monthly subcutaneous injections of ofatumumab bested daily 14-mg teriflunomide (Aubagio) oral tablets in reducing annualized relapse rates (ARR), 3-month confirmed disability progression, and the number of gadolinium-enhancing T1 and new or enlarging T2 lesions in relapsing MS.
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