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 20+ countries, with results reported as conclusion of the studies & highlighted at the North American Cystic Fibrosis Conference in Sep 2024
- P-III studies in CF patients (≥12yrs.) showed that Alyftrek met its 1EP of ppFEV1 non-inferiority & 2EP of SwCl improvement vs Trikafta. In children (6–11yrs.), the drug demonstrated safety (1EP) as well as benefits in ppFEV1 & SwCl
Ref: Vertex | Image: Vertex | Press Release
Related News:- Ionis’ Tryngolza (Olezarsen) Receives the US FDA’s Approval to Treat Adults with Familial Chylomicronemia Syndrome (FCS)
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