Biogen/AbbVie Withdraws Multiple Sclerosis Drug

Biogen and AbbVie have announced the worldwide withdrawal of Zinbryta (daclizumab)for relapsing multiple sclerosis (MS) due to safety concerns, including reports of severe liver damage and immune-related conditions. The companies said that “characterizing the complex and evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated.”

FDA approved Zinbryta 5/2016 as a long-acting injection that is self- administered by the patient monthly. At the time of approval, the agency said it 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.