FDA extends action date for Novartis application for ofatumumab in MS

The FDA has notified Novartis (NYSE:NVS) that it needs more time to review its supplemental marketing application seeking approval to use Arzerra (ofatumumab) to treat patients with relapsing forms of multiple sclerosis (MS).

The new action date will be in September.

The CD20-directed cytolytic antibody is currently approved in the U.S. for chronic lymphocytic leukemia.

The company expects a regulatory nod in Europe by Q2 2021.

https://seekingalpha.com/news/3579832-fda-extends-action-date-for-novartis-application-for-ofatumumab-in-ms