Vertex secures two FDA wins for cystic fibrosis, both with boxed ...
Dec 23, 2024 · Cystic fibrosis is a life-threatening genetic disorder that causes sticky mucus to build up in the lungs and digestive system. Credit: Iren_Geo via Shutterstock. Vertex Pharmaceuticals has secured two simultaneous US Food and Drug Administration (FDA) approvals for cystic fibrosis (CF) treatments ...
Vertex Announces U.S. FDA Approval for Trikafta …
About Cystic Fibrosis. Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 92,000 people globally. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract.
Vertex Announces US FDA Approval of ALYFTREK™, a Once-Daily …
Dec 20, 2024 · About Cystic Fibrosis. Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 92,000 people globally. ... in cystic fibrosis. Today Vertex CF medicines are treating over 68,000 people with CF across more than 60 countries on six continents. This represents 2/3 of the diagnosed people with CF eligible for CFTR ...
Vertex wins FDA nod for once-daily cystic fibrosis triplet
Dec 23, 2024 · The FDA has approved Vertex’s Alyftrek, a once-daily triple combination for the treatment of cystic fibrosis in people 6 years and older who have mutations that are amenable to the therapy, the ...
Vertex Announces US FDA Approval of ALYFTREK™, a Once-Daily …
BOSTON, December 20, 2024 -- (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK...
Vertex Wins FDA Approval for New Cystic Fibrosis Option but
Dec 23, 2024 · It’s welcome good news for Vertex following last week’s subpar clinical results for its non-opioid analgesic. Vertex Pharmaceuticals said Friday the FDA has approved its next cystic fibrosis product Alyftrek, clearing the biotech to market a product designed to improve on Trikafta.
FDA Approves Trikafta for 94 Additional Rare CFTR Mutations
Dec 20, 2024 · The approval enables a small number of people with cystic fibrosis in the U.S. who were not previously eligible for a CFTR modulator therapy to access a drug that treats the underlying cause of their disease for the first time.. The FDA based its decision on laboratory evidence submitted by Vertex Pharmaceuticals that demonstrates these CFTR mutations respond to Trikafta and on established ...
Vertex Gains FDA Approval for Cystic Fibrosis Drug Alyftrek
Dec 20, 2024 · Vertex Pharmaceuticals said the Food and Drug Administration approved a new treatment for cystic fibrosis. The treatment, called alyftrek, is designed to treat cystic fibrosis in patients six...
Vertex's Cystic Fibrosis Drug Alyftrek Gets FDA Approval
Dec 20, 2024 · Alyftrek is a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people 6 years and...
Vertex Highlights First Oral Presentation of Phase 3 Clinical Data …
Sep 26, 2024 · Vertex also announced presentations describing long-term outcomes in people with cystic fibrosis (CF) ages 2 to 11 years taking TRIKAFTA ®, demonstrating consistent and sustained improvements across multiple measures of disease.
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