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New EU Filings Include A Range Of First-Of-Their-Kind Therapies

 
• By Neena Brizmohun

Pridopidine, sebetralstat and mirdametinib, which are novel treatments that are yet to be approved anywhere in the world, are among the latest products for which marketing applications are now under review by the European Medicines Agency.

Pridopidine could become the first treatment for Huntington’s disease with the ability to impact progression • Source: Shutterstock

Pridopidine, Prilenia Therapeutics’ drug candidate for treating Huntington’s disease, and sebetralstat, KalVista Pharmaceuticals’ investigational oral, on-demand therapy for hereditary angioedema, are among the latest products that the European Medicines Agency has started reviewing for potential pan-EU marketing authorization.

Key Takeaways
  • The European Medicines Agency started reviewing the EU marketing authorization applications for 10 new drugs on 15 August.
  • The drugs comprise pridopidine, sebetralstat, mirdametinib, lifileucel, zuranolone,...

Pridopidine, if approved, could become the first treatment for Huntington’s disease with the ability to impact progression, according to Prilenia. The company is also in dialog with the Food and...

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• By Neena Brizmohun

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More from Geography

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
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