by IainBate
10. May 2012 14:39
The FDA and the EMA are to review Biogen Idec’s marketing application for BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS).
BG-12 is the only known investigational compound for the treatment of MS that has experimentally demonstrated activation of the Nrf-2 pathway.
It has demonstrated significant reductions in MS disease activity, coupled with favourable safety and tolerability in two separate Phase III clinical trials.
Last year, Biogen published data from the DEFINE and CONFIRM global clinical trials that demonstrated BG-12’s effectiveness in patients taking the treatment either twice or three times a day over a period of two years.
As a result, the FDA has now accepted Biogen’s New Drug Application and granted the company a standard review timeline. In addition, the EMA has validated a similar application for review.
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Tags: FDA, EMA, FDA review, EMA review, marketing authorisation, Marketing Authorisation Application, MAA, BG-12, dimethyl fumarate, multiple sclerosis, MS, DEFINE trial, CONFIRM trial, New Drug Application
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