FDA Approves Ofatumumab for Relapsing MS

August 21, 2020

For multiple sclerosis, the therapy will be sold as Kesimpta by Novartis; it is administered by patients once a month through the Sensoready autoinjector pen.

The FDA on Thursday approved a new version of a biologic—already indicated for chronic lymphocytic leukemia (CLL)— as a self-administered injection for relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Ofatumumab was first approved by the FDA in 2009 for the treatment of CLL as an intravenous infusion. In CLL, the anti-CD20 monoclonal antibody is marketed under the name Arzerra.

For MS, the therapy will be sold as Kesimpta by Novartis; it is administered by patients once a month through the Sensoready autoinjector pen. Novartis said it anticipates the therapy to become available in the United States next month, with an expected approval in Europe by the first half of 2021.

For use in MS, ofatumumab was investigated in a new clinical development program in RMS involving more than 2300 patients worldwide.

It is a precision targeted B-cell agent, and in a statement, Novartis said B-cell agents, which bind to and deplete B-cells linked to MS disease activity, have previously only been available hospitals or infusion centers.

The approval is based on data from the phase 3 ASCLEPIOS I and II trials, which compared the drug with teriflunomide. The trials randomly assigned 946 patients to receive ofatumumab and 936 to receive teriflunomide. Results showed that annualized relapse rates (ARR) for patients with MS were reduced by 51% and 58% in those who received ofatumumab in the ACLEPIOS I and II trials, respectively; both differences achieved statistical significance (P < .001)

NeurologyLive noted that Thursday's news comes after a June announcement by Novartis that the FDA had delayed its regulatory decision on ofatumumab.