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FDA approves Zinbryta for use in MS treatment

6/2/2016

The U.S. Food and Drug Administration approved Zinbryta™ (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis. Zinbryta is a long-acting injection that is self-administered by the patient monthly.

The effectiveness of Zinbryta was shown in two clinical trials. One trial compared Zinbryta and Avonex in 1,841 participants who were studied for 144 weeks. Patients on Zinbryta had fewer clinical relapses than patients taking Avonex. The second trial compared Zinbryta with placebo and included 412 participants who were treated for 52 weeks. In that study, those receiving Zinbryta had fewer relapses compared to those receiving placebo.

Zinbryta should generally be used only in patients who have had an inadequate response to two or more MS drugs because Zinbryta has serious safety risks, including liver injury and immune conditions. Because of the risks, Zinbryta has a boxed warning and is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.

Biogen and AbbVie plan to make Zinbryta available in the third quarter of 2016. Biogen and AbbVie will provide a variety of support services for people affected by relapsing MS, including financial assistance programs, through Above MSTM (www.abovems.com). For more information on Zinbryta, including prescribing information and the medication guide, visit Zinbryta.com.



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