In the race to provide competition to Novartis' pill Gilenya, Sanofi says that the US Food and Drug Administration has accepted for review its submission seeking approval of Aubagio for relapsing forms of multiple sclerosis.
The French drugmaker made the announcement as it presented new data on the drug at the ECTRIMS/ACTRIMS meeting in Amsterdam. Earlier results from the TEMSO Phase III trials showed that Aubagio (teriflunomide) significantly reduced the risk of annual relapses, the primary endpoint, by 31% for 7mg and 14mg doses.
The new data demonstrated that annualised rate of relapses leading to hospitalisation was significantly reduced by 36%for the lower dose of Aubagio and by 59% for the 14mg dose compared with placebo. The risk of hospitalisation per relapse was significantly reduced by 43% for the higher dose of Aubagio, but by only 6% at the 7mg dose.
Sanofi R&D chief Elias Zerhouni said that the additional data "further supports the potential of teriflunomide as a new once-a-day oral therapy". The company added that it expects to file an application for regulatory approval with the European Medicines Agency in the first quarter of 2012.
At the moment, the only MS pill on the market is Novartis' Gilenya (fingolimod), but there are a number of oral treatments in the pipeline, not just Aubagio. One of the treatments exciting analysts most is Biogen Idec's BG-12 (dimethyl fumarate), and full details of that drug and news on the rest of Biogen's MS franchise will be covered in PharmaTimes World News next week.