Novartis' sBLA for Ofatumumab Gets Extended Review From FDA

Novartis AG NVS announced that the FDA has extended the review period of its supplemental biologics license application (sBLA) for ofatumumab (OMB 157) by three months. The sBLA is seeking approval for subcutaneous ofatumumab, a novel B-cell to treat patients with relapsing multiple sclerosis (RMS).

As a result, the regulatory body will now announce its decision in September 2020 instead of the previously anticipated date in June.

Notably, in February 2020, the FDA and the European Medicines Agency (EMA) accepted Novartis’ sBLA and marketing authorization application (MAA), respectively, for ofatumumab to address RMS. The filings were based on data from the phase III ASCLEPIOS I and II studies.

While the FDA was expected to deliver its verdict this month, approval in Europe is expected in the second quarter of 2021.

Per the company, on approval, ofatumumab will have the potential to become a first-choice treatment for a broad RMS population and the first B-cell therapy that can be self-administered at home using an autoinjector pen.

Ofatumumab is marketed by Novartis for oncology indications as an intravenous infusion under the brand name, Arzerra.

Shares of Novartis have declined 8.7% so far this year compared with the industry’s decrease of 1.7%.

In March 2020, Johnson & Johnson JNJ also submitted a new drug application (NDA) to the FDA seeking approval for ponesimod to treat adults with RMS.  Notably, a marketing application seeking a regulatory nod for ponesimod in Europe was also filed in March.

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. Israel-based Teva Pharmceuticals TEVA has long been in this market with its widely-used drug Copaxone, which has now lost patent protection. Besides, generics are rapidly eroding its revenues.

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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