The U.S. Food and Drug Administration (FDA) approved Kesimpta in August 2020 for the treatment of adults with relapsing multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
According to Novartis, which manufactures Kesimpta, this is the first MS therapy targeting B-cells that the FDA approved and that can be administered at home. The treatment is given once per month, via under-the-skin injection using the Sensoready Pen.
Other regulatory filings seeking approval for Kesimpta as an MS treatment elsewhere in the world are ongoing; a decision in the European Union is expected in the first half of 2021.
How does Kesimpta work?
MS is an autoimmune disease in which the body’s immune system mistakenly attacks and damages the myelin sheath, the protective protein layer that insulates nerve fibers.
The exact mode of action by which Kesimpta alters relapse and remission in MS is still uncertain. Researchers know that the treatment targets B-cells by binding to the CD20 protein found on their surface. They think that this leads to a decrease in the number of these immune cells that attack the myelin sheath.
Kesimpta in clinical trials
Preclinical studies in animal models produced promising results that helped the developers proceed to Phase 1 clinical trials, in which the safety of Kesimpta was tested among healthy volunteers. With positive safety and toxicity findings from these trials, the companies moved forward to Phase 2 and 3 trials.