Approval of Kaftrio-Kalydeco for CF children 2-5y.o. in Europe HCFA TEAM November 24, 2023

Approval of Kaftrio-Kalydeco for CF children 2-5y.o. in Europe

Good news for CF children!

European Commission approved Kaftrio in combination with Kalydeco for the treatment of children with Cystic Fibrosis 2-5 years old. 

“As CF starts in early childhood and is a progressive disease, it is important to treat people with CF as early as possible. With the approval of KAFTRIO for children as young as 2 years, we can now treat young children with a medicine that has the potential to slow disease progression by addressing the underlying cause of the disease,” said Professor Marcus A. Mall, M.D., Head of the Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine at Charité Universitätsmedizin Berlin.

At the same time, European Medicines Agency validation for Marketing Authorization Application extension for Kaftrio in combination with Kalydeco  to include CF patients with responsive rare mutations was announced.

More information here and here.

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