Please visit our MS learning channel on YouTube, which provides hundreds of MS related topics from many of our video recorded education programs and archived here: -- Be empowered with MS views and news. Opt-in with us:

~~ Scroll left side of this blog for needed resources. Also, use our 'search by topic' tool, to find specific information.

Disclaimer: 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.


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

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.
For more information on PLEGRIDY, visit

To comment - click the comment link shown below
Share our Articles with others
MS Views and News / Stu's Views & MS News 
provide education, information and resources 
for those affected by Multiple Sclerosis

To Keep CURRENT  and up to date with MS News and Information
Sign-up at: 


JOIN our Facebook Page:


Thank you   

Stu's Views & MS News, is a publication of: 

No comments: