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Vertex’s Trikafta Receives the US FDA’s Approval for the Treatment of Children with Cystic Fibrosis Aged 2 Through 5 Years

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Vertex’s Trikafta Receives the US FDA’s Approval for the Treatment of Children with Cystic Fibrosis Aged 2 Through 5 Years

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  • The US FDA has approved the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children aged 2-5yrs. with CF with 1 F508del mutation in the CFTR gene or a mutation in the CFTR gene responsive to Trikafta based on in vitro data
  • The approval was based on the 24wk. two-part P-III trial evaluating Trikafta which showed that the therapy was well tolerated with a safety profile consistent with that observed in older age groups, improvement in sweat chloride concentration, a measure of CFTR function & lung function. The results were published in the AJRCCM
  • The therapy was approved in the US, Canada, Switzerland, Australia, New Zealand & Israel, EU, the UK, Iceland, Liechtenstein & Norway as Kaftrio in combination with Kalydeco

Ref: Businesswire | Image: Vertex

Related News:- Vertex Receives the Health Canada Marketing Authorization for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat Cystic Fibrosis

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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