Vertex secures two FDA wins for cystic fibrosis

Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from Trikafta kicks off
As Vertex Pharmaceuticals reels from a painful trial readout for its pain candidate suzetrigine, the Boston biotech has chalked up a win in its specialty area of cystic fibrosis. | The FDA has approved Vertex’s Alyftrek,
US FDA approves Vertex Pharma's triple combo cystic fibrosis treatment
The U.S. Food and Drug Administration has approved Vertex Pharmaceuticals' next-generation treatment for a rare and progressive genetic disease, the company said on Friday, expanding its dominance in the market for cystic fibrosis.
Vertex Wins FDA Approval for New Cystic Fibrosis Option but Stock Still Down
The new combination, dubbed Alyftrek, is designed to improve on the Trikafta, a product that generated sales of $8.9 billion in 2023. It’s welcome good news for Vertex following last week’s subpar clinical results for its non-opioid analgesic.
Vertex drug for cystic fibrosis wins approval
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Alyftrek Gets FDA Approval for Cystic Fibrosis
The Food and Drug Administration (FDA) has approved Alyftrek ™ (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene.
Vertex wins approval for new once-daily CF drug
Vertex Pharmaceuticals Inc. notched two FDA victories late Friday for its cystic fibrosis medicines, increasing the number of patients eligible for its drugs and likely boosting its own future revenue.
BX-004 by BiomX for Cystic Fibrosis: Likelihood of Approval
BX-004 is under development for the treatment of cystic fibrosis, non-cystic fibrosis bronchiectasis and resistant pseudomonas aeruginosa infections. It is administered as inhalational formulation. The drug candidate comprises of cocktail of natural phages developed based on BOLT (Bacteriophage Lead to Treatment) platform.
FDA approves Alyftrek once-daily oral combination for cystic fibrosis
The US Food and Drug Administration has approved Alyftrek, a once-daily oral combination of vanzacaftor, tezacaftor, and deutivacaftor, for the treatment of cystic fibrosis (CF) in adults
Vertex Secures FDA Approval for New Cystic Fibrosis Drug Alyftrek
Vertex Pharmaceuticals VRTX announced that the FDA has approved its next-in-class vanza triple therapy for treating people with cystic fibrosis (CF) aged six years and above. The drug will be marketed under the brand name Alyftrek.
Vertex secures two FDA wins for cystic fibrosis, both with boxed warnings
Vertex has won two cystic fibrosis approvals from the FDA, but the agency included high-level safety warnings.
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