FDA approves self-administered Kesimpta for MS

The US Food and Drug Administration has approved Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Developed by Swiss pharma giant Novartis (NOVN: VX), Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide and is a first-choice treatment option for RMS patients. Kesimpta is the first B-cell therapy that can be self-administered once monthly at home via the Sensoready autoinjector pen.

The drug is being developed and marketed worldwide by Novartis under a license agreement with Danish biotech firm Genmab (Nasdaq: GMAB).