Vertex withdraws EU filings for toddler CF drugs

The European Medicines Agency said on September 18 that Vertex Pharmaceuticals (Ireland) Limited had withdrawn applications to extend Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Kalydeco (ivacaftor) to children aged one year and older with cystic fibrosis, used together as a combination regimen. The notice came in the CHMP highlights from the committee's September 14-17 meeting, which listed the pair among three already-authorised medicines whose indication-extension filings were pulled. Existing EU approvals for older patients are not themselves revoked by the withdrawals.