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

 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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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