CHMP Gives Positive Opinion for Biogen Idec’s Plegridy to Treat Multiple Sclerosis
Biogen Idec said European drug reviewers have recommended marketing authorization of its drug Plegridy (peginterferon beta-1a); a pegylated interferon administered subcutaneously for adults with relapsing-remitting multiple sclerosis.
The Committee for Medicinal Products for Human Use’s positive opinion, announced Friday, will be referred to the European Commission, which grants marketing approval for medicines in the EU. Its decision is expected within the next few months, the company said.
The committee’s opinion is based on Phase 3 data from ADVANCE, a 1,500 patient study conducted with an interferon treatment in MS. First year data from ADVANCE showed that Plegridy, dosed once every two weeks, significantly reduced annualized relapse rate (ARR) at one year by 36 percent compared to placebo, Biogen Idec said.
The Weston, Mass.-based company said Plegridy also reduced the risk of 12-week confirmed disability progression by 38 percent compared to placebo. In addition, the drug considerably reduced the number of new or newly enlarging T2-hyperintense lesions.
Biogen Idec said the year two ADVANCE positive efficacy and safety data was consistent with the results observed in year one. — Kellen Owings
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