Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic Fibrosis
Vertex's vanzacaftor/tezacaftor/deutivacaftor triple therapy NDA accepted by FDA for cystic fibrosis, targeting those aged 6+ with at least one F508del or responsive mutation in CFTR gene. PDUFA action date set for January 2, 2025, with EMA validation also received.
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Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic Fibrosis
Vertex's vanzacaftor/tezacaftor/deutivacaftor triple therapy NDA accepted by FDA for cystic fibrosis, targeting those aged 6+ with at least one F508del or responsive mutation in CFTR gene. PDUFA action date set for January 2, 2025, with EMA validation also received.