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Biogen & AbbVie's Multiple Sclerosis Drug Gets FDA Nod

Biogen Inc. BIIB and AbbVie Inc. ABBV have gained FDA approval for their multiple sclerosis (MS) treatment, Zinbryta. The once-monthly, self-administered, subcutaneous treatment has been approved for relapsing forms of multiple sclerosis (RMS) in patients who have had an inadequate response to two or more MS therapies.

FDA approval makes Zinbryta the first once-monthly, self-administered MS treatment to be approved. Approval comes with a black box warning regarding the risk of hepatic injury, including autoimmune hepatitis, and other immune-mediated disorders. Moreover, only prescribers, pharmacies and patients enrolled in the Zinbryta Risk Evaluation and Mitigation Strategy (REMS) Program, which includes required monthly liver function tests, will have access to the treatment.

Zinbryta is currently under regulatory review in the EU, Switzerland, Canada and Australia. EU approval should come shortly considering the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion in late April.

Zinbryta’s approval comes as a boost for Biogen, which already has a strong position in the MS market. However, Biogen has been facing its share of troubles in this market following the emergence of a progressive multifocal leukoencephalopathy (PML)-related death of a patient on the company’s oral MS treatment, Tecfidera. Biogen’s interferon business is also facing challenges with the market shifting towards orals. The company has been working on strengthening its position in the MS market and recently decided to spin-off of its hemophilia business so that it can focus on developing and bringing neurology products to market. The company plans to speed up its efforts to bring new treatments for MS, spinal muscular atrophy (SMA), Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and neuropathic pain to market.

Meanwhile, AbbVie is looking to strengthen its product portfolio and diversify its revenue base. With quite a few companies working on bringing biosimilar versions of Humira, AbbVie’s flagship product, to market, AbbVie has been working on reducing its dependence on Humira.

While Biogen is a Zacks Rank #3 (Hold) stock, AbbVie is a Zacks Rank #5 (Strong Sell) stock. Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company BMY and Pfizer, Inc. PFE – both Zacks Rank #1 (Strong Buy) stocks.

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