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Biogen Idec receives CHMP backing for Plegridy approval
Biogen Idec has announced that its new multiple sclerosis drug Plegridy has been recommended for EU approval by the Committee for Medicinal Products for Human Use (CHMP).
The European Medicines Agency committee has endorsed the marketing authorisation of the pegylated interferon therapy, which is administered subcutaneously among adults with relapsing-remitting multiple sclerosis.
Data from clinical trials have shown the drug is able to offer safety, efficacy and convenience benefits. It has been studied among more than 1,500 patients, helping to reduce relapse rates and disability progression.
A final decision on the approval of Plegridy will be issued by the European Commission in the coming months.
Dr Douglas Williams, Biogen Idec's executive vice-president of research and development, described the drug as "a unique treatment option that combines efficacy, a favourable safety profile consistent with the established interferon class and a once-every-two-week dosing schedule".
This comes after the company received European approval for another new multiple sclerosis therapy, Tecfidera, earlier this year.
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