The U.S. Food and Drug Administration (FDA) has announced the approval of ofatumumab (Kesimpta) injection for treating adults with relapsing forms of multiple sclerosis (MS).
The agency approved this self-administered, targeted B-cell therapy for relapsing-remitting MS, active secondary progressive MS, and clinically isolated syndrome, which can be delivered through an auto-injector pen.
Novartis, a Swiss multinational pharmaceutical company, develops Kesimpta.
Dr. Stephen Hauser, director of the Weill Institute for Neurosciences at the University of California San Francisco, said, “This approval is wonderful news for patients with relapsing multiple sclerosis. 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.”
Dr. Hauser is also co-chair of the phase 3 studies that were part of the basis for the approval from the FDA.
Bruce Bebo, Executive Vice President of research at the National MS Society, said it is important to have a range of treatment options because the response to disease-modifying treatments varies among individuals with MS.
He said, “We are pleased to have an additional option approved for the treatment of relapsing forms of MS.”
Novartis said, “The drug is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion.”
Based on the findings of two clinical studies, the FDA approved ofatumumab. The findings were published in the New England Journal of Medicine.
The studies assessed the safety and efficacy of the drug in more than 1880 adult patients with MS.
The FDA said the most commonly observed side effects of Kesimpta were upper respiratory tract infection, headaches, and injection-related reactions.
The federal agency first approved the drug in 2009 for the treatment of chronic lymphocytic leukemia (CLL). However, it was administered as a high-dose IV infusion by a medical provider.
Novartis said, “This is a different dosing regimen and route of administration than was previously approved for the CLL indication.” The company said Kesimpta will be available in the United States in the next month.