Novartis AG NVS announced that the FDA has approved the supplemental biologics license application (sBLA) for its novel B-cell therapy Kesimpta (ofatumumab). The drug is now approved as a subcutaneous injection for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) including a clinically isolated syndrome, relapsing-remitting disease and an active secondary progressive disease.

The FDA nod was based on data from the phase III ASCLEPIOS I and II studies. Results showed that treatment with Kesimpta demonstrated superiority over Sanofi’s SNY Aubagio (teriflunomide) in significantly reducing the annualized relapse rate (ARR), which was the primary endpoint, three-month confirmed disability progression (CDP) and the number of gadolinium-enhancing (Gd+) T1, and new or enlarging T2 lesions1.

In February 2020, the FDA and the European Medicines Agency (EMA) accepted Novartis’ sBLA and the marketing authorization application (MAA), respectively, for ofatumumab to address RMS.

Later in June, the FDA extended the review period of the sBLA for ofatumumab by three months with decision expected in September 2020. Therefore, the above-mentioned approval comes before the scheduled date.

The drug is also under review in Europe with a decision expected in the second quarter of 2021.

Shares of Novartis have declined 8% so far this year against the industry’s increase of 1.8%.

Ofatumumab is already marketed by Novartis for oncology indications as an intravenous infusion under the brand name Arzerra. In December 2015, Novartis in-licensed rights to ofatumumab from GlaxoSmithKline GSK for all indications including RMS.

We remind investors that multiple sclerosis is a crowded market with many companies jostling for space with drugs in their portfolio already approved for the same indication. Biogen BIIB holds a strong position with a wide range of products including Avonex, Tysabri, Tecfidera and Plegridy.

Zacks Rank

Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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