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Vertex Secures FDA Approval for New Cystic Fibrosis Drug Alyftrek
Post the FDA’s approval, the orally administered Alyftrek has been approved for use in CF patients aged six years and older who have at least one F508del mutation or another responsive mutation ...
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Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del TRIKAFTA-Responsive Variants
With this approval, 94 additional non-F508del CFTR mutations have been added to the TRIKAFTA label, and approximately 300 additional people with CF in the U.S. are now eligible for a medicine to ...
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Vertex secures two FDA wins for cystic fibrosis, both with boxed warnings
Alyftek is approved for use with CF patients aged six years or older who have at least one F508del mutation or another CFTR mutation responsive to the therapy. It builds on the success of Trikafta ...
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FDA Approval Increases Eligibility for Cystic Fibrosis Medication Trikafta
An additional 94 non-F508del CFTR mutations and a boxed warning on liver injury and liver failure were included in the updated prescribing information. 1507_1515del9, 2183A→G, A1067P ...