Vertex Pharmaceuticals’ Alyftrek Receives the CHMP’s Positive Opinion for the Treatment of Cystic Fibrosis

SRShots: The CHMP has recommended Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat patients (≥6yrs.) with cystic fibrosis (CF), having at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Alyftrek is approved in the US and UK and is under review in Canada, Switzerland, Australia, and New ZealandVanzacaftor &…

ByRidhi RastogiMay 1, 2025

News

The US FDA Approves Vertex’s Alyftrek for the Treatment of Cystic Fibrosis

Shots: The US FDA has approved Alyftrek (QD, CFTR modulator) to treat patients (≥6yrs.) with cystic fibrosis (CF), having at least one F508del mutation or another CFTR gene mutation. Submissions are under review in the EU, UK, Canada, Switzerland, Australia & New Zealand Approval was supported by pivotal P-III CF program involving >1,000 patients across…

ByDipanshu DixitDecember 20, 2024

News

Vertex Receives CHMP’s Positive Opinion for Kalydeco as a Treatment of Cystic Fibrosis in Infants

Shots: The company received the CHMP’s positive opinion for the label expansion of Kalydeco (Ivacaftor) to include the treatment of infants (aged 1mos.-4mos.) with cystic fibrosis with specific mutations in the CFTR gene (R117H/G551D/G1244E/G1349D/G178R/G551S/S1251N/S1255P/S549N/S549R) Kalydeco has been approved by the EU for the treatment of cystic fibrosis patients aged ≥4mos. with specific CFTR gene mutations …

ByDipanshu DixitFebruary 23, 2024

INSIGHTS+

Top Performing Drug – Trikafta/Kaftrio (May Edition)

Shots:In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have covered Trikafta/Kaftrio as the top-performing drug of the monthTrikafta is a combination of ivacaftor, tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis in pediatric patients who have at least one…

BySenior EditorMay 24, 2023

VIEWPOINTS

James Graham, CEO of Recce Pharmaceuticals Shares Insights from the Expansion and Acceleration of Clinical Programs

Shots:James gave an overview of the timeline of Recce Pharmaceuticals' clinical programs with several significant data read-outs in 2022 and 2023He emphasized the study design and results from the different infectious disease clinical and preclinical programs in its product portfolioThe interview highlights how the development and commercialization of New Classes of Synthetic Anti-Infectives…

BySenior EditorApril 18, 2023

Vertex Pharmaceuticals’ Alyftrek Receives the CHMP’s Positive Opinion for the Treatment of Cystic Fibrosis

The US FDA Approves Vertex’s Alyftrek for the Treatment of Cystic Fibrosis

Vertex Receives CHMP’s Positive Opinion for Kalydeco as a Treatment of Cystic Fibrosis in Infants

Top Performing Drug – Trikafta/Kaftrio (May Edition)

James Graham, CEO of Recce Pharmaceuticals Shares Insights from the Expansion and Acceleration of Clinical Programs

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Vertex Pharmaceuticals’ Alyftrek Receives the CHMP’s Positive Opinion for the Treatment of Cystic Fibrosis

The US FDA Approves Vertex’s Alyftrek for the Treatment of Cystic Fibrosis

Vertex Receives CHMP’s Positive Opinion for Kalydeco as a Treatment of Cystic Fibrosis in Infants

Top Performing Drug – Trikafta/Kaftrio (May Edition)

James Graham, CEO of Recce Pharmaceuticals Shares Insights from the Expansion and Acceleration of Clinical Programs

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Vertex Receives CHMP’s Positive Opinion for Kalydeco as a Treatment of Cystic Fibrosis in Infants