Two Hemophilia Treatments Among 15 New EU Filings

 
• By Neena Brizmohun
  
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EU marketing authorization applications for a number of new medicines have started the regulatory review process.

gene therapy
The EMA is reviewing a marketing application for a new gene therapy for hemophilia B • Source: Shutterstock

The European Medicines Agency has started reviewing 15 new products for potential pan-EU marketing approval, including two hemophilia treatments – fidanacogene elaparvovec, Pfizer/Spark Therapeutics’ gene therapy for hemophilia B, and efanesoctocog alfa, Sobi/Sanofi’s recombinant factor VIII therapy for hemophilia A.

Key Takeaways

  • The European Medicines Agency has added 15 new products to its list of medicines that are under review for potential pan-EU marketing authorization.

  

Fidanacogene elaparvovec, for severe and moderately severe hemophilia B, is an investigational, one-time treatment that Pfizer explained is designed to...

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