First self-administered monthly injection for MS approved in United States

摘要

Zinbryta (daclizumab), the first once-monthly self-administered injection for multiple sclerosis (MS), has been approved by the US Food and Drug Administration (FDA). The injection can be used in adults with relapsing forms of MS and will be comarketed by Biogen and AbbVie. However, the FDA, which is responsible for evaluating the safety and efficacy of medicines in the United States, has recommended that the drug is prescribed only to patients who have had an "inadequate response to two or more MS drugs" because of serious safety concerns, including liver injury and immune conditions. Because of these risks, the drug comes with a boxed warning.