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

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