Aubagio (teriflunomide) and Tecfidera (BG-12) move closer to European approval(22/03/13)

The Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on two new MS therapies. Recommending the granting of a marketing authorisation for the medicinal product Tecfidera 120 mg and 240 mg, gastro-resistant hard capsules, intended for the treatment of adult patients with relapsing remitting multiple sclerosis and Aubagio 14 mg film-coated tablet intended for the treatment of multiple sclerosis. 

The Committee also concluded that the active substance contained in Aubagio, teriflunomide, could not be considered to be a new active substance. It is expected that Sanofi-aventis will appeal against this conclusion.

The full Summaries Of Opinion can be read here: Tecfidera , Aubagio 

Source: The Committee for Medicinal Products for Human Use (CHMP) (22/03/13)