Vertex Gets CHMP Positive Opinion for Kaftrio With Ivacaftor

By Michael Dabaie

Vertex Pharmaceuticals Inc. said it received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP.

The positive CHMP opinion was for the label extension of Kaftrio, or ivacaftor/tezacaftor/elexacaftor, in a combination with ivacaftor 150 mg tablets for the treatment of cystic fibrosis in patients 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene. The company said that is the most common CF-causing mutation worldwide.

If the European Commission follows the recommendation, the majority of people with CF in Europe will be eligible for the medicine, Vertex said.

The CHMP positive opinion was based on results from a Phase 3 study. It showed statistically significant and clinically meaningful improvements in primary and key secondary objectives, including lung function in patients treated with ivacaftor/tezacaftor/elexacaftor in combination with ivacaftor, the company said.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

March 26, 2021 08:20 ET (12:20 GMT)

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