NAPSR News: Biogen Idec Scores FDA Approval of PLEGRIDY™ to treat Multiple Sclerosis

WASHINGTON - Aug. 18, 2014 - PRLog -- On Friday, August 15, 2014, Biogen Idec announced the U.S. Food and Drug Administration’s (FDA) approval of PLEGRIDY^TM (peginterferon beta-1a) to treat patients with relapsing forms of multiple sclerosis (RMS). PLEGRIDY is administered as a subcutaneous injectable therapy and is dosed every two weeks. The therapy will available in a PLEGRIDY PEN which is a ready- to- use auto injector.

“PLEGRIDY offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “PLEGRIDY represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them.”

The approval was based on the results acquired from the Phase 3 study called ADVANCE, involving more than 1,500 MS patients. ADVANCE was conducted over the period of two years and was a placebo-controlled (year one) study evaluating the efficacy and safety of PLEGRIDY administered subcutaneously. According to the company, the clinical results confirmed:

·         PLEGRIDY 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, by 38 percent (p=0.0383) compared to placebo

·         PLEGRIDY also significantly reduced the number of new gadolinium-enhancing [Gd+] lesions by 86 percent (p<0.0001) and reduced new or newly enlarging T2-hyperintense lesions by 67 percent (p<0.0001) compared to placebo.

“PLEGRIDY is a compelling new treatment option for people living with MS that offers a proven safety profile, strong efficacy and an every two week dosing schedule administered by an innovative delivery system,” said Peter Wade, M.D., medical director for neurology at the Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research in Hartford, CT. “As a treating neurologist, I believe these attributes will appeal to MS patients who look for less frequent dosing with proven effectiveness.”

PLEGRIDY has already been approved by the European Commission, and with the FDA approving the therapy to be marketed in the U.S this will certainly enhance Biogen Idec’s presence as a key player in the MS market.  According to EvaluatePharma, the estimated sales will be more than $1 billion by 2020.

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