FDA Extends Review of BG-12 in MS

Susan Jeffrey

October 19, 2012

The US Food and Drug Administration (FDA) has extended review of BG-12 (dimethyl fumarate) for an additional 3 months, Biogen Idec has announced.

The Prescription Drug User Fee Act (PDUFA) date for review of the New Drug Application for BG-12, Biogen's now much anticipated oral candidate for treatment of relapsing multiple sclerosis (MS), has been pushed back 3 months, a standard extension period.

"The FDA has indicated that the extension of the PDUFA date is needed to allow additional time for review of the application," a statement from the company notes. "The agency has not asked for additional studies."

The drug is also under review by regulatory authorities in the European Union, Australia, Canada, and Switzerland, the statement notes.

The application is based on findings from the Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS (DEFINE) trial and the Comparator and an Oral Fumarate in RRMS (CONFIRM) trial, both published in the September 20 issue of the New England Journal of Medicine. The trials were funded by Biogen Idec.

Full results of the 2 phase 3 trials evaluating the effect of oral BG-12 in patients with MS show the investigational agent reduced relapse rates, disease activity on imaging, and, in 1 trial, progression of disability.