Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Receives the US FDA’s Approval in Children Aged 6 to 11 with Certain Mutations in Cystic Fibrosis

June 10, 2021 Auto Bot approval, Cystic fibrosis, FDA, regulatory, Vertex 0

Shots:

  • The approval is based on a P-III study evaluating the safety, PK & efficacy of Trikafta in 66 children aged 6-11yrs. old with CF with either two copies of F508del mutations or one copy of F508del mutation & one minimal function mutation for 24wks.
  • The company has filed the application in EMA & MHRA and plans to file for expanded use in Switzerland, Australia & Israel in 2021. Additionally, a new dosage strength of Trikafta is now available (elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 75 mg and ivacaftor 75 mg)
  • Trikafta is an approved therapy for patients aged ≥12yrs. with CF with certain mutations in the US, Switzerland, Australia, Israel, EU & UK as Kaftrio + Kalydeco

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

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