“In Phase 3 clinical trials, across a broad range of genotypes, once-daily ALYFTREK demonstrated non-inferiority to TRIKAFTA in ppFEV 1 response and statistically significant improvement in ...
Participants were randomly assigned to receive Trikafta or placebo based on age and weight: Aged 6 to < 12 years and less than 30 kg: morning dose of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor ...
Sales are expected to surpass that total in 2024. Like Vertex’s top-selling drug Trikafta, Alyftrek is a three-drug combination that uses a compound called tezacaftor as its chemical backbone. The two ...
Courtesy of Gunnar Esiason After a few particularly nasty years battling CF, Gunnar entered into a clinical trial in 2018 for a drug called Trikafta, which had received funding from the Boomer ...
Gunnar even proposed to Darcy while ice skating. Courtesy of Gunnar Esiason After a few particularly nasty years battling CF, Gunnar entered into a clinical trial in 2018 for a drug called Trikafta, ...
It will be marketed as Alyftrek. Vertex also won expanded approval for Trikafta, which was first approved in 2019. Trikafta has become Vertex’s (Nasdaq: VRTX) blockbuster CF drug, helping drive ...
The Phase 3 studies in people with CF ages 12 years and older met their primary endpoint (non-inferiority on absolute change from baseline in ppFEV1 compared to TRIKAFTA) and all key secondary ...
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 ...
The FDA on Friday issued two simultaneous cystic fibrosis approvals for Vertex Pharmaceuticals but included high-level safety warnings for both.
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. William Blair analysts see ...
Separately, the FDA expanded the indication for Vertex's Trikafta on Friday to include cystic fibrosis patients with additional genetic variants. The FDA initially approved Trikafta in 2019 for ...
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