Vertex' Dueling Phase III Programs Pay Off In NDA Submission Speed
Next-generation CFTR corrector elexacaftor aims to be first cystic fibrosis product with minimal function mutations claim after winning out over VX-659 thanks to tolerability advantage in dueling Phase III programs testing combination with the components of Vertex’ Symdeko.
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Keeping Track: Vertex’ Trikafta Speeds To US Approval; New Indications For AZ’s Farxiga, J&J’s Stelara, GSK’s Zejula
The latest drug development news and highlights from our US FDA Performance Trackers.
The US FDA cleared the combination in just three months for patients with the most common genetic mutation. Company sets price above double regimen Symdeko, but in line with trailblazer Kalydeco.
Vertex’s triple combination regimen for cystic fibrosis and two Ebola vaccines from Janssen are among the latest potential new products being considered for accelerated assessment by the European Medicines Agency.