Sanofi’s Aubagio And Biogen Idec’s Tecfidera Make It A Good Day For MS Sufferers At EMA
This article was originally published in The Pink Sheet Daily
The EMA’s CHMP has given the nod to Sanofi’s Aubagio and Biogen Idec’s Tecfidera for multiple sclerosis, setting the scene for a European three-way battle with Novartis’ Gilenya in the coming months.
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The EU’s top drug advisory committee was divided on how to interpret regulations on new active substance status when it came to Sanofi's oral MS drug Aubagio, which was only given NAS status by a majority vote after the French group appealed an initial refusal. The CHMP’s thinking on the issue will be useful to others wishing to develop new medicines closely related to already-marketed products.
EU regulators, industry and researchers remain at odds on the level of transparency needed in clinical trials, despite a fast approaching deadline and efforts by EFPIA and PhRMA to break the diplomatic logjam.
FDA approved the oral multiple sclerosis drug March 27 to treat patients with relapsing forms of the disease. Labeling includes data from one trial that showed patients on Tecfidera experienced disability progression less often.