Vertex Gets CHMP Positive Opinion for Kaftrio With Ivacaftor
26 March 2021 - 11:35PM
Dow Jones News
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 michael.dabaie@wsj.com
(END) Dow Jones Newswires
March 26, 2021 08:20 ET (12:20 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Vertex Pharmaceuticals (NASDAQ:VRTX)
Historical Stock Chart
From Apr 2024 to May 2024
Vertex Pharmaceuticals (NASDAQ:VRTX)
Historical Stock Chart
From May 2023 to May 2024
