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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)
Key Takeaways
  • Developers of three drugs are this week due to attend oral explanation meetings in front of the EMA’s human medicines committee, the CHMP, to argue the case for why their drugs should be awarded marketing authorization in the EU.
  • Two orphans are on the list, troriluzole for treating spinocerebellar ataxia, and  givinostat for treating Duchenne muscular dystrophy.
  • The third drug is clascoterone for treating acne.

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...

Two other products – Italformaco’s orphan drug givinostat, for treating Duchenne muscular dystrophy (DMD), and Cosmo Pharmaceuticals’ acne drug clascoterone – are also the topics of...

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