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Two Hemophilia Treatments Among 15 New EU Filings

 
• By Neena Brizmohun

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.

  • The 15 products are: fidanacogene elaparvovec, efanesoctocog alfa, apadamtase alfa/cinaxadamtase alfa, capivasertib, insulin icodec, iptacopan, vibegron, omalizumab, rituximab, dasatinib, eribulin, two denosumab drugs and two ustekinumab drugs

Fidanacogene elaparvovec, for severe and moderately severe hemophilia B, is an investigational, one-time treatment that Pfizer explained is designed to enable patients to produce factor IX

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