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Friday, September 19, 2014

Detailed results from Biogen Idec and Abbvie’s pivotal phase 3 decide study further define the efficacy and safety profile of Zinbryta™

Publication date: 18 September 2014

Today Biogen Idec (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced the full results from the Phase 3 DECIDE clinical trial, which show ZINBRYTA™ (daclizumab high-yield process), dosed subcutaneously once a month, demonstrated a statistically significant improvement in reducing disease activity in people with relapsing-remitting multiple sclerosis (RRMS) compared to AVONEX® (interferon beta-1a).1

These results are being presented at the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS) in Boston.

“The full results from DECIDE demonstrate that ZINBRYTA significantly improved key measures of multiple sclerosis disease activity compared to AVONEX, including reducing annualized relapse rate and new brain lesion development,” said Ludwig Kappos, M.D., chair,  Department of Neurology and head, MS-Research Group, University Hospital, Basel, Switzerland, and lead investigator for DECIDE. “These results help us better understand ZINBRYTA as a potential treatment option for people with relapsing-remitting MS.”

DECIDE Detailed Efficacy Results1

DECIDE was a two- to three-year, Phase 3, global, randomized, double-blind study that evaluated whether ZINBRYTA would provide superior outcomes for certain clinical endpoints compared to AVONEX. The study enrolled more than 1,800 patients with RRMS.
Primary Endpoint:1
  • Patients on ZINBRYTA demonstrated a statistically significant 45 percent reduction in annualized relapse rate (ARR) compared to patients treated with AVONEX (p<0.0001).
Secondary Endpoints:1
  • ZINBRYTA demonstrated superiority in reducing the number of new or newly enlarging T2-hyperintense lesions at week 96, with a 54 percent reduction relative to AVONEX (p<0.0001).
  • The risk of three-month confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), was reduced by 16 percent in patients treated with ZINBRYTA compared to those on AVONEX (p=0.16). This was not statistically significant.
  • Seventy-three percent of ZINBRYTA patients were relapse-free compared to 59 percent of AVONEX patients (p<0.0001) at week 96.
  • The risk of meaningful worsening in the physical impact of multiple sclerosis (MS) (> 7.5 point worsening in the Multiple Sclerosis Impact Scale [MSIS-29] physical score) was reduced by 24 percent in the ZINBRYTA group compared to the AVONEX group (p=0.018).
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