Shots:

• The EMA's CHMP has adopted a positive opinion for the label extension of Kaftrio in combination with ivacaftor to treat CF in patients aged 6 to11 yrs. who have at least one F508del mutation in a CFTR gene
• The combination therapy showed improvements in lung function, sweat chloride & respiratory symptoms, safety & tolerability profile were consistent with that observed in patients aged =12yrs.
• Kaftrio + ivacaftor is approved in the EU for the treatment of CF in patients aged =12yrs. who have at least one copy of the F508del mutation in the CFTR gene

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