The approval was anticipated due to compelling clinical trial results. These trials showcased Alyftrek's comparable effectiveness to Trikafta in terms of lung function, measured by percent predicted ...
The drug is also eligible for use in CF patients who have discontinued Trikafta or Vertex’s other CF medicines. Similar regulatory filings are also under review in Europe. However, the drug’s ...
Rollout for the drug should be rapid, but switching dynamics with Trikafta, the company’s other drug for CF, could take some time given its “excellent clinical profile,” the firm adds.
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 ...
and lower sweat chloride levels than Trikafta, is another step in achieving this goal,” he added. Unfettered access to industry-leading news, commentary and analysis in pharma and biotech. Updates ...
TRIKAFTA, a combination of elexacaftor, tezacaftor, and ivacaftor, is designed to enhance the function of the defective protein caused by cystic fibrosis transmembrane conductance regulator (CFTR) ...