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Successful Phase 3 results for daclizumab

  • Joint developers Biogen (BIIB) and AbbVie (ABBV) announce positive top-line results for a Phase 3 clinical trial comparing subcutaneous daclizumab high-yield process (DAC-HYP) to intramuscular interferon beta-1a as a treatment for relapsing-remitting multiple sclerosis (RRMS). DAC-HYP achieved its primary endpoint of a statistically significant 45% reduction in annualized relapse rate.
  • It also achieved statistical significance on the first secondary endpoint by demonstrating superiority compared to interferon beta-1a in reducing new or newly-enlarging T2-hyperintense lesions at week 96 by 54%. It did not achieve statistical significance in the second secondary endpoint of reducing the risk of three month disability progression as measured by EDSS.
  • The companies plan to work with regulators to determine the appropriate timelines for filings.
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