Clinical Data
The FDA approval of ZINBRYTA is primarily based on results from two clinical trials, including DECIDE, the largest and longest head-to-head Phase 3 clinical trial ever conducted in MS. The Phase 2b SELECT and Phase 3 DECIDE studies were global, randomized, double-blind, controlled studies that involved approximately 2,400 people living with RMS. Some patients in DECIDE were treated for up to three years.In DECIDE and SELECT, ZINBRYTA significantly reduced the annualized relapse rate (ARR), the primary endpoint of the studies, by 45 percent compared to AVONEX up to 144 weeks and by 54 percent compared to placebo at 52 weeks (both p<0.0001), respectively."MS patients are in need of therapeutic choices to help manage their disease and ZINBRYTA is an important new option for patients," saidMichael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie is committed to making a remarkable impact on the lives of patients, including in MS where there are particular unmet needs."Results from DECIDE showed that ZINBRYTA demonstrated superior efficacy across multiple measures of MS disease activity (relapses and MRI) compared to AVONEX, including a significant reduction in the mean number of new or newly enlarging T2-hyperintense lesions by 54 percent compared to AVONEX at 96 weeks (p<0.0001).Additionally, the study showed at up to 144 weeks on ZINBRYTA, 67 percent of patients were relapse free compared to 51 percent of the patients taking AVONEX.The ZINBRYTA label includes a boxed warning for the risk of hepatic injury, including autoimmune hepatitis, and other immune-mediated disorders. Because of these risks, access to ZINBRYTA in the United States is restricted to prescribers, pharmacies and patients enrolled in the ZINBRYTA Risk Evaluation and Mitigation Strategy (REMS) Program, which includes required monthly liver function tests.