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Friday, May 23, 2014
CHMP Adopts Positive Opinion for PLEGRIDY™ (Peginterferon Beta-1a) as a Treatment for Multiple Sclerosis in the European Union
May 23, 2014
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Biogen Idec (BIIB) today received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of PLEGRIDY™ (peginterferon beta-1a), a pegylated interferon administered subcutaneously for adults with relapsing-remitting multiple sclerosis (RRMS).
The CHMP’s positive opinion is now referred to the European Commission (EC), which grants marketing authorization for medicines in the EU.
“The CHMP’s positive opinion for PLEGRIDY marks an important milestone in bringing a meaningful treatment advance to people with MS in the EU,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. “We believe PLEGRIDY will offer physicians and those living with MS a unique treatment option that combines efficacy, a favorable safety profile consistent with the established interferon class, and a once-every-two-week dosing schedule.”
The CHMP opinion is primarily based on Phase 3 data from ADVANCE, one of the largest studies conducted with an interferon treatment in MS, which included more than 1,500 MS patients. Data from the first year of ADVANCE demonstrated that PLEGRIDY, dosed once every two weeks, significantly reduced annualized relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007). PLEGRIDY reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0383) compared to placebo. PLEGRIDY also significantly reduced the number of new or newly enlarging T2-hyperintense lesions compared to placebo. The ADVANCE two-year data was consistent with the positive efficacy and safety results observed in year one.
“In PLEGRIDY, we have a potential treatment that offers a less frequent dosing schedule, while providing robust clinical and MRI results,” said Professor Dr. Bernd C. Kieseier, Heinrich-Heine Universität. “These factors combined with the known safety profile of the interferon class, make it a compelling option for patients with RRMS.”
The safety and tolerability profile of PLEGRIDY observed in ADVANCE was consistent with that of established MS interferon therapies. The most commonly reported adverse drug reactions (ADRs) with PLEGRIDY treatment (incidence ≥10% and at least 2% more frequent on PLEGRIDY than on placebo) were injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia.
Following the opinion adopted by the CHMP, a decision from the EC is expected within the coming months.