CHMP Thinking On Aubagio NAS Status Offers Useful Insights
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
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