CHMP Thinking On Aubagio NAS Status Offers Useful Insights

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.

Deciding how different Sanofi's oral multiple sclerosis therapy Aubagio (teriflunomide) is to a previously marketed medicine split the Committee for Medicinal Products for Human Use (CHMP), with nine members dissenting from the majority view of around 27 members that Aubagio was indeed a new active substance (NAS).

The European Medicines Agency’s top advisory committee had originally decided against granting NAS status to Aubagio when it released a...

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