Novartis sBLA for Ofatumumab in Multiple Sclerosis

FDA has extended by three months its review of a Novartis supplemental BLA for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. The revised user fee review action date is now expected in September.

Ofatumumab is a fully human anti-CD20 monoclonal antibody that is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion, according to the company. “The selective mechanism of action and subcutaneous administration of ofatumumab allows precise delivery to the lymph nodes, where B-cell depletion in [multiple sclerosis] is needed, and may preserve the B-cells in the spleen, as shown in preclinical studies,” it says.

Ofatumumab was developed by Genmab and licensed to GlaxoSmithKline; Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications in 12/2015.