The Food and Drug Administration on Thursday approved Kesimpta, formerly known as ofatumumab, a drug developed by Novartis for patients with the relapsing form of multiple sclerosis, the most common form of the disease.

Novartis will have to wait a little longer to see if the U.S. Food and Drug Administration (FDA) will greenlight Arzerra (ofatumumab) as a treatment for patients with relapsing multiple sclerosis (RMS).

On Tuesday, the FDA extended its review of the Supplemental Biologics License Application for Arzerra in this indication by three months. Regulatory action is now expected in September 2020, the company said. Novartis did not disclose any reason for the regulatory delay in its announcement.

Novartis has reported new data with its multiple sclerosis (MS) drug ofatumumab showing that it can suppress disease activity for up to two years, as it waits for an FDA decision on the drug next month.

New drugs for breast cancer, lymphoma, multiple sclerosis and migraine are among new product launches this year that could top $1 billion in annual sales by 2024, according to Clarivate.

Novartis said that its human anti-CD20 monoclonal antibody ofatumumab (OMB157) showed superiority over Aubagio (teriflunomide) in two phase 3 trials in patients with relapsing forms of multiple sclerosis (RMS).

Swiss drugmaker Novartis on Friday stepped up its challenge to Roche’s multiple sclerosis franchise, highlighting study results for its MS hopeful ofatumumab that could compete with its cross-town rival’s drug Ocrevus.

Chiasma hopes to be able to file its oral acromegaly therapy by year-end, and Novartis wants to shore up its MS franchise.