Zinbryta Injection for Multiple Sclerosis Wins FDA Approval

The monthly injectable comes with a boxed warning for severe liver injury.

The US FDA has approved Zinbryta (daclizumab) for the treatment of relapsing multiple sclerosis (MS) in adults. The once-monthly, subcutaneous injection is self-administered.

Due to its safety profile, the drug, which is manufactured and marketed by Biogen and AbbVie, comes with a boxed warning and is reserved for patients who have had an inadequate response to 2 or more therapies indicated for the treatment of MS.

FDA approval was primarily based on the results of 2 clinical trials, Phase 2b SELECT and Phase 3 DECIDE, in which Zinbryta went head-to-head with Avonex. That study demonstrated a superior efficacy for Zinbryta in the reduction of annualized relapse rate, mean number of new or enlarging T2-hyperintense lesions, and percentage of patients who were relapse-free at up to 144 weeks.

Due to the risk of hepatic injury, including autoimmune hepatitis, Zinbryta will only be distributed to prescribers, pharmacies, and patients enrolled in the Zinbryta Risk Evaluation and Mitigation Strategy Program, which requires monthly liver function testing.

Other adverse reactions to Zinbryta when compared to Avonex include nasopharyngitis, upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal pain, bronchitis, eczema, and enlargement of lymph nodes. When compared to placebo, patients taking Zinbryta were more likely to report depression, rash, and increases alanine aminotransferase.

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