Shots: The approval is based on P-III ARRIVAL study results assessing Kalydeco in 25 children with CF who have either of 10 mutations in CFTR gene (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D or R117H) P-III ARRIVAL results: mean baseline sweat chloride level (SCL) (104.1 mmol/L); @24wks. SCL (33.8 mmol/L); patient with paired […]Read More
Shots: The approval is based on P-III study results assessing Orkambi in 60 patients with CF, who have two copies of the F508del CFTR mutation aged 6 to 11 years for 24 wks. The P-III study demonstrated in reduction of sweat chloride by 31.7 mmol/L and was well-tolerated, Presented at European Cystic Fibrosis Society Conference in June 2018 Orkambi is a combination […]Read More
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