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Today Biogen Idec (NASDAQ: BIIB) announced the positive, full first-year results from its two-year pivotal Phase 3 ADVANCE study of PLEGRIDY™
(peginterferon beta-1a), the company’s investigational candidate for relapsing-remitting multiple sclerosis (RRMS) dosed once every two weeks or every four weeks. These data, presented today at the American Academy of Neurology’s 65th Annual Meeting, indicate that PLEGRIDY significantly reduced multiple sclerosis (MS) disease activity, including relapses, disability progression and brain lesions, compared to placebo at one year.
“These full first-year results provide a more complete picture of PLEGRIDY and its positive effects on the reduction of relapse, disability progression and lesion development,” said Peter Calabresi, M.D., director, the Johns Hopkins Multiple Sclerosis Center. “These data suggest that, if approved, PLEGRIDY may offer the benefit of a less frequent dosing schedule, which would be a meaningful advance for people living with MS.”
Study Results for Two-Week Dosing Arm at Year One:Primary endpoint:
PLEGRIDY met the primary endpoint of reducing annualized relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007).
PLEGRIDY reduced the proportion of patients who relapsed by 39 percent compared to placebo (p=0.0003).
PLEGRIDY reduced the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans by 67 percent compared to placebo (p<0.0001).
PLEGRIDY also demonstrated significant positive effects on disability progression by reducing the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent compared to placebo (p=0.0383).
PLEGRIDY significantly reduced the number of gadolinium-enhancing (Gd+) lesions by 86 percent compared to placebo (p<0.0001).
The incidence of PLEGRIDY neutralizing antibodies was less than 1 percent.
PLEGRIDY dosed once every four weeks was also shown to be effective, and met the primary and secondary endpoints in the ADVANCE trial. PLEGRIDY dosed once every two weeks resulted in a numerically greater treatment effect across these relapse and MRI endpoints discussed above.