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news.US-based Biogen Idec has received a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of Plegridy (peginterferon beta-1a) indicated to treat relapsing-remitting multiple sclerosis (RRMS).
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Plegridy is an investigational subcutaneous injectable therapy for RRMS, in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body.
The positive opinion is now referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU).
Biogen Idec executive vice president of Research and Development Douglas Williams said the CHMP’s positive opinion for Plegridy marks an important milestone in bringing a meaningful treatment advance to people with MS in the EU.
"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," Williams said.
The CHMP opinion is based on data from a Phase III ADVANCE trial carried out with an interferon treatment in MS, which included over 1,500 MS patients.
Data from the first year of ADVANCE trial showed that Plegridy, dosed once every two weeks, significantly reduced annualized relapse rate (ARR) at one year by 36% compared to placebo (p=0.0007).
The drug reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38% compared to placebo.
It also significantly reduced the number of new or newly enlarging T2-hyperintense lesions compared to placebo.
The company said that the safety and tolerability profile of the drug observed in ADVANCE trial was consistent with that of established MS interferon therapies.