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

Based on favorable results obtained from the ADVANCE Phase 3 Study, the FDA approval of PLEGRIDY™ signifies a blockbuster therapeutic achievement for Biogen Idec .
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WASHINGTON - Aug. 18, 2014 - PRLog -- On Friday, August 15, 2014, Biogen Idec announced the U.S. Food and Drug Administration’s (FDA) approval of PLEGRIDYTM (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.

With such industry leaders paving the way with new beneficial therapeutic breakthroughs, they will need both certified and qualified individuals to promote their diversified product portfolio. When industry leaders look for new candidates for sales/marketing positions, they look toward individuals that are industry trained. Companies are looking for people that have the background to sell their product both proficiently and efficiently.

The CNPR is a federally trademarked certification you can earn by demonstrating the necessary knowledge in pharmacology, medical terminology, physiology, and regulations for selling pharmaceuticals. The CNPR examination is dedicated to increasing the professional level of NAPSR members and to developing meaningful and ethical standards fully accepted by both its members and members of the pharmaceutical community.

The CNPR® Program represents a level of industry achievement and a demonstrated knowledge of pharmacology, medical terminology, pharmaceutical selling guidelines, physician selling techniques and industry standards. Pharmaceutical sales candidates who have this training will differentiate themselves from other individuals looking for open positions. Upon successful completion of the training each student will receive the Certification Mark of the CNPR®. CNPR® graduates should immediately utilize the NAPSRx® Career Center to apply for pharmaceutical sales positions.

Individuals that are interested in becoming a Certified National Pharmaceutical Representative (CNPR) can contact the National Association of Pharmaceutical Sales Representatives(NAPSRx) for more information.

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