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Sponsors Of Two Orphans And An Acne Treatment To Defend Marketing Authorization Applications At EMA

 
• By Francesca Bruce

Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.

Three companies are scheduled to defend their products at a CHMP oral explanation meeting this week. (Shutterstock)

Biohaven Bioscience is this week scheduled to argue that its orphan drug troriluzole should be awarded EU marketing authorization during an oral explanation before the European Medicines Agency’s human medicines committee, the CHMP. The drug, if authorized, could become the first-approved treatment for the ultra-rare condition spinocerebellar ataxia.

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