Extension of indication and new examination following submission of new data
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Clinical Benefit
Substantial
In patients age 6 years and older and who have one of the following gating (class III) mutation in the CFTR gene G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R, the actual benefit is substantial.
Clinical Added Value
important
KALYDECO provides a substantial improvement in actual benefit (level II in the treatment of cystic fibrosis in patients age 6 years and older and who have one of the following gating (class III) mutation in the CFTR gene”: G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
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