- The FDA has approved Vertex Pharmaceuticals Incorporated’s (NASDAQ: VRTX) expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 6 through 11 years.
- The approval covers children who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene responsive to Trikafta vitro data.
- Trikafta was previously approved by the FDA for use in people with cystic fibrosis 12 years and older with at least one copy of the F508del mutation or one copy of a mutation that is responsive in vitro.
- Additional dosage strength of Trikafta tablets is now available (elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 75 mg and ivacaftor 75 mg) in connection with this approval.
- The company has submitted applications for the use of Trikafta in children ages 6 through 11 years to the regulatory authorities in Europe and the U.K. It plans to file for this expanded use in Switzerland, Australia, and Israel in 2021.
- Price Action: VRTX shares are up 0.9% at $213 during the premarket session on the last check Wednesday.
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