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Biogen, AbbVie Report Positive Top-Line Results from Phase 3 Trial of Daclizumaba for MS

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Today Biogen Idec (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced positive
top-line results from the Phase 3 DECIDE clinical trial, designed to evaluate
the superiority of once-monthly, subcutaneous daclizumab high-yield process
(DAC HYP) when compared to intramuscular interferon beta-1a (IFN β-1a), as a
potential treatment for relapsing-remitting multiple sclerosis (RRMS), the
most common form of multiple sclerosis (MS). Results showed that DAC HYP was
superior on the study's primary endpoint, demonstrating a statistically
significant 45 percent reduction in annualized relapse rate (ARR) compared to
IFN β-1a (p<0.0001).

“The results of the DECIDE study are compelling, with DAC HYP demonstrating
robust efficacy compared to a current standard of MS care,” said Gilmore
O'Neill, vice president, Global Neurology Clinical Development, Biogen Idec.
“As a potential once-monthly therapy with a novel mechanism of action, we
believe that, if approved, DAC HYP will be an important treatment option for
people living with MS.”

“The positive results in the DECIDE study represent achievement of an
important milestone in the development of DAC HYP as a potential new treatment
option for MS patients,” said Michael Severino, M.D., executive vice
president, Research and Development and chief scientific officer, AbbVie.
“Together, the companies are committed to working with regulatory agencies on
filing plans for DAC HYP.”

DAC HYP showed superiority on the first secondary endpoint, number of new or
newly enlarging T2-hyperintense lesions at week 96, with a 54 percent
reduction relative to IFN β-1a (p<0.0001). On the second secondary endpoint,
DAC HYP reduced the risk of three month confirmed disability progression as
measured by the Expanded Disability Status Scale (EDSS) by 16 percent over IFN
β-1a, which was not statistically significant (p=0.16). Using a pre-specified
sensitivity analysis that accounted for 67 patients who did not have a
confirmatory disability assessment, DAC HYP showed a 21 percent reduction in
the risk of sustained disability progression (p=0.047).

The safety profile of DAC HYP in the study was consistent with what has been
observed in prior studies. The overall incidence of adverse events was
comparable across the DAC HYP and IFN β-1a treatment groups. In patients
treated with DAC HYP compared to IFN β-1a, there was an increased incidence of
serious infections (4 percent vs. 2 percent), serious cutaneous reactions (2
percent vs. < 1 percent), and elevations of liver transaminases greater than 5
times the upper limit of normal (6 percent vs. 3 percent). There were 4 deaths
in the IFN β-1a group and 1 death in the DAC HYP group, none of which was
considered treatment related.

Biogen Idec and AbbVie plan to work with regulatory agencies to determine
appropriate timelines for filing. The companies intend to present detailed
results from DECIDE at a future medical conference.

Posted-In: News FDA Press Releases

 

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