Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Receives the US FDA’s Approval to Treat the Underlying Cause of Cystic Fibrosis

 Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Receives the US FDA’s Approval to Treat the Underlying Cause of Cystic Fibrosis

Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Receives the US FDA’s Approval to Treat the Underlying Cause of Cystic Fibrosis

Shots:

  • The approval is based on two global P-III studies assessing Trikafta in 403 & 107 patients with CF aged ≥12yrs. with at least one F508del mutation and one minimal function mutation (F/MF) & in people with two F508del mutations (F/F) for 24wks. & 4wks. respectively
  • The two P-II studies result demonstrated improvement in FEV1 and respiratory symptoms in F/MF study @24wks. with a reduction in the rate of pulmonary exacerbations and improvements in BMI
  • Trikafta is a prescription therapy to treat CF, currently being evaluated in P-III study in patients aged 6-11yrs with F/MF and F/F CF mutations and will be evaluated in children aged <6yrs. Vertex has submitted EMA’s MAA for the combination regimen

Click here to­ read full press release/ article | Ref: Vertex | Image: Wbur

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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