VRTX CHMP opinion: Thursday, July 23, 2026

EventCHMP opinion
DateThursday, July 23, 2026
MarketUS listing
SourceEMA CHMP · confidence 90% · primary source ↗

Variation type II · Kaftrio · Update of section 5.1 of the SmPC in order to introduce newly tested ELX/TEZ/IVA-responsive FRT mutations, based on results from the nonclinical study report U032 version 3.0; this is an in vitro pharmacological profiling of cystic fibrosis transmembrane conductance reg

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