Biogen Idec’s Plegridy accepted for regulatory review

Biogen Idec has announced that Plegridy, its new treatment for relapsing forms of multiple sclerosis, has been accepted for regulatory review in the US and EU.

Both the US Food and Drug Administration and the European Medicines Agency have accepted marketing authorisation applications for the pegylated subcutaneous injectable candidate, which has demonstrated its potential benefits in phase III clinical trials.

Results from the two-year global Advance study showed that Plegridy significantly reduced disease activity including relapses, disability progression and brain lesions compared to placebo, as well as offering positive safety and tolerability profiles at one year.

Dr Douglas Williams, Biogen Idec's executive vice-president of research and development, said: "Plegridy, if approved, could offer a less frequent dosing schedule, a favourable safety profile and the potential to become the preferred interferon treatment."

Biogen Idec shored up its multiple sclerosis portfolio earlier this year by acquiring full strategic, commercial and decision-making rights to the successful therapy Tysabri from partner Elan.