Zinbryta Gains FDA Approval for Relapsing MS
The Food and Drug Administration (FDA) has approved Zinbryta (daclizumab; Biogen and AbbVie) for the treatment of relapsing forms of multiple sclerosis (RMS). Zinbryta should generally be reserved for use in patients with an inadequate response to 2 or more therapies indicated for the treatment of RMS.
The approval was based on data from 2 clinical trials, including the Phase 2b SELECT and Phase 3 head-to-head DECIDE trial. These global, randomized, double-blind, controlled studies evaluated approximately 2,400 patients with RMS. For both studies, treatment with Zinbryta significantly reduced the annualized relapse rate, the primary endpoint, by 45% compared to Avonex up to 144 weeks, and by 54% compared to placebo at 52 weeks (both P values <0.0001), respectively. Data from DECIDE demonstrated superior efficacy of Zinbryta across multiple measures of MS disease activity vs. Avonex, including a significant reduction in the mean number of new or newly enlarging T2-hyperintense lesions by 54% vs. Avonex at 96 weeks (P<0.0001). At 144 weeks, 67% of patients treated with Zinbryta were relapse-free vs. 51% of patients treated with Avonex.
Zinbryta carries a boxed warning for the risk of hepatic injury, including autoimmune hepatitis and other immune-mediated disorders. Due to these safety risks, access to Zinbryta is limited to prescribers, pharmacies, and patients enrolled in the Zinbryta Risk Evaluation and Mitigation Strategy (REMS) Program, which requires monthly liver function tests.
The precise mechanism of Zinbryta, an interleukin-2 (IL-2) receptor blocking antibody, in multiple sclerosis is unknown but is presumed to involve modulation of IL-2 mediated activation of lymphocytes through binding to CD25, a subunit of the high-affinity IL-2 receptor.
Zinbryta is a once-monthly subcutaneous treatment available as a 150mg/mL solution single-dose prefilled syringe.
For more information call (800) 456-2255 or visit Zinbryta.com.