Vertex: FDA Approves SYMDEKO treatment for peds cystic fibrosis

-SYMDEKO is now approved for patients 6 years of age and older with two copies of the F508del mutation or one copy of a responsive mutation-

-Vertex’s third medicine approved to treat the underlying cause of CF in eligible patients in this age range-

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved SYMDEKO^® (tezacaftor/ivacaftor and ivacaftor) for use in children with cystic fibrosis ages 6 through 11 years who have two copies of the F508del-CFTR mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to SYMDEKO. It was previously approved by the FDA for use in patients with cystic fibrosis 12 years and older with two copies of the F508del mutation or one copy of a responsive mutation in the U.S. An additional dosage strength of SYMDEKO tablets is now available (tezacaftor 50 mg/ivacaftor 75 mg and ivacaftor 75 mg) in connection with this approval.

“Today’s expanded approval of SYMDEKO in children ages 6 through 11 is an important step in our efforts to continue to bring treatment options to the youngest patients possible and importantly brings us closer to our goal of developing medicines for all people living with CF,” said Reshma Kewalramani, M.D., Executive Vice President and Chief Medical Officer at Vertex.

https://www.marketscreener.com/VERTEX-PHARMACEUTICALS-11321/news/Vertex-Pharmaceuticals-FDA-Approves-SYMDEKO-tezacaftor-ivacaftor-and-ivacaftor-to-Treat-the-Und-28795508/