FDA Gives Nod to Zinbryta for MS Patients

Jun 01, 2016

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

“Zinbryta provides an additional choice to patients who may require a new option for treatment,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

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. The drug is manufactured by Biogen Inc., Cambridge, Massachusetts. Read the full release

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