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EMA To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 
• By Francesca Bruce

The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

The EMA's human medicines committee will this week issue opinions on whether 19 medicines should be approved in the EU. (Shutterstock)
Key Takeaways
  • The European Medicines Agency’s human medicines committee, the CHMP, is this week set to decide whether 19 new medicines should be approved for use in the EU.
  • Orphan drugs dominate the list of drugs to be discussed, including treatments for cystic fibrosis and cutaneous T-cell lymphoma.
  • Europe’s potentially first treatment for thyroid eye disease, teprotumumab, is also up for an opinion.

Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), Vertex Pharmaceuticals’ next generation treatment for cystic fibrosis (CF) is one of eight orphan products that the European Medicines Agency could this week recommend for pan-EU marketing approval

Alyftrek and Kinselby are among 19 products in total listed on the draft agenda of the latest monthly meeting of the EMA’s human medicines committee, the CHMP, which is

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