Biogen, AbbVie's Once-Monthly MS Injection Approved in U.S.

By George Stahl 

U.S. regulators approved the once-monthly, self-administered injection to treat multiple sclerosis made by Biogen Inc. and AbbVie Inc., but with a warning about the drug causing possible liver damage.

Biogen and AbbVie are co-promoting daclizumab in the U.S. Pricing information for the drug -- which also is known by its marketing name of Zinbryta -- wasn't immediately available.

The U.S. Food and Drug Administration approved daclizumab for patients with relapsing-remitting multiple sclerosis, the most common form of the condition. Because of the drug's safety profile, daclizumab should be reserved for patients who have had an inadequate response to two or more multiple sclerosis therapies, the companies said.

In the U.S., the drug will carry a boxed warning for risk of liver injury and immune-mediated disorders. It also will include warnings and precautions for acute hypersensitivity, infections, depression and suicide.

Multiple sclerosis is a chronic inflammatory condition that occurs when the body essentially attacks its own central nervous system. It can be disabling in advanced stages. Common multiple sclerosis treatments are injected on a daily or weekly basis.

European regulators have recommended daclizumab for approval, the companies said, and the drug is under review in Switzerland, Canada and Australia.

Based on studies, the companies said, daclizumab reduced the annualized relapse rate, the primary endpoint of the studies, by 45% compared with a leading multiple sclerosis drug and 54% compared with a placebo.

Write to George Stahl at [e-mail]

(END) Dow Jones Newswires

May 27, 2016 22:56 ET (02:56 GMT)

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