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FDA accepts 3 supplemental applications from Vertex for expanded use of CF meds

September 1, 2020

The FDA has accepted for review three supplemental marketing applications from Vertex Pharmaceuticals (NASDAQ:VRTX) seeking expanded labels for cystic fibrosis (CF) meds  TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO (tezacaftor/ivacaftor and ivacaftor) and KALYDECO (ivacaftor) to include additional rare CFTR mutations.

The filings may also allow certain CF patients who are currently eligible for KALYDECO to become eligible for SYMDEKO or TRIKAFTA and certain people currently eligible for SYMDEKO may become eligible for TRIKAFTA.

The agency’s action date is December 30.

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