The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the new drug Alyftrek™ for the treatment of patients with Cystic Fibrosis 6 years and older with at least one non-class I mutation, Vertex Pharmaceuticals announced.
The new medicine consists of the active substances deivacaftor/tezacaftor/vanzacaftor and is administered once daily, offering ease of intake and improved compliance with treatment. Phase 3 clinical studies have shown that Alyftrek™ is as effective as Kaftrio® in improving respiratory function, while showing a higher reduction in sweat sodium chloride levels.
Final approval of the new medicine by the European Commission is expected within the next few months. If approved, Alyftrek™ will provide a new treatment option for thousands of Cystic Fibrosis patients in Europe.
For more information, please visit the official Vertex Pharmaceuticals announcement: https://investors.vrtx.com/news-releases/news-release-details/vertex-receives-chmp-positive-opinion-alyftrekr-new-once-daily