FDA to Review Trikafta for Patients as Young as 6

FDA to Review Trikafta for Patients as Young as 6

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FDA to Review Trikafta for Patients as Young as 6

The U.S. Food and Drug Administration (FDA) has accepted for review an application to expand the use of Trikafta as a treatment in children with cystic fibrosis (CF) ages 6 to 11 with at least one F508del mutation in the CFTR gene (the gene defective in CF) or a CFTR mutation that is responsive to the therapy. The supplemental mew drug application was submitted last year by Vertex Pharmaceuticals, Trikafta’s developer, after the Phase 3 AURORA clinical trials (NCT03525444 and NCT03525548)…

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