Biogen, AbbVie's Once-Monthly MS Injection Approved in U.S.
May 27 2016 - 11:11PM
Dow Jones News
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 george.stahl@wsj.com
(END) Dow Jones Newswires
May 27, 2016 22:56 ET (02:56 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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