Additional CFTR variants for ivacaftor treatment approved by FDA

The drug label for ivacaftor was recently amended and has been approved by the FDA.

Ivacaftor was originally indicated only for use in Cystic Fibrosis patients with one or two copies of the G551D variant within the CFTR gene. In the amended ivacaftor drug label, the indication has been changed to include 8 additional CFTR variants:

G1244E (rs267606723)                       S1251N (rs74503330)

G1349D (rs193922525)                      S1255P (rs121909041)

G178R (rs80282562)                           S549N (rs121908755)

G551S (rs121909013)                         S549R (rs121908757 and rs121909005). 

• View the FDA-approved ivacaftor drug label with relevant highlighted pgx information.
• View the CPIC dosing guidelines for ivacaftor based on CFTR genotype.
• View clinical annotations for ivacaftor.