Biogen Idec’s BG-12 accepted for EU and US review

Biogen Idec has announced that its promising new multiple sclerosis (MS) drug BG-12 has been accepted for regulatory review in the US and Europe.

The US Food and Drug Administration has accepted the company's new drug application and granted BG-12 a standard review timeline, while a marketing authorisation application has also been validated by the European Medicines Agency.

BG-12 has also been submitted for review in Canada and Switzerland and is an oral therapeutic candidate that has experimentally demonstrated activation of the Nrf-2 pathway.

The submissions are based on results from a comprehensive phase III clinical development programme, during which the drug demonstrated significant reductions in MS disease activity, coupled with favourable safety and tolerability.

Biogen Idec is also currently conducting an extension study called Endorse in order to assess the long-term performance of the drug.

Earlier this month, the company published its financial report for the first quarter of 2012, highlighting a seven percent year-on-year growth in sales.