Novartis wins FDA approval for MS drug

Aug. 21, 2020

Novartis announced that the U.S. FDA approved the company's relapsing-multiple-sclerosis drug, Kesimpta (ofatumumab) after two Phase 3 studies.

Ofatumumab was first approved by the FDA in 2009 for the treatment of chronic lymphocytic leukemia (CLL) as an intravenous infusion with a high dose, administered by a healthcare provider. The newest approval is 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.

Traditionally, B-cell treatments, which bind to and deplete B-cells associated with disease activity in MS, have predominantly been available in hospitals or infusion treatment centers, which can add costs to the health care system and present a lifestyle burden for some patients. Kesimpta gives patients the flexibility of self-administering at home with an autoinjector pen once-monthly.

The drug will go up against Genentech's (the U.S. unit of Roche) Ocrevus, which was was approved in 2017 for relapsing forms of MS and primary progressive multiple sclerosis (PPMS). Ocrevus is administered by intravenous infusion at an infusion center.

Read the Novartis press release