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# Novartis sBLA for Ofatumumab in Multiple Sclerosis
- URL: https://www.fdaweb.com/novartis-sbla-for-ofatumumab-in-multiple-sclerosis/
- Published: 2020-06-03T12:00:00.000Z
- Updated: 2026-09-14T16:17:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146916

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.