For treating cystic fibrosis in patients 12 years or older and who have 2 copies of F5o8del mutations in the CFTR gene.
Approximately 50% of the 30,000 patients with cystic fibrosis in the US have 2 copies of the F5o8del mutation in the CFTR G and would be eligible to take this drug combination.
Phase 3 studies show a 3% improvement in lung function over placebo.
Dosage is 2 pills every 12 hours.
Side effects include: Shortness of breath, upper respiratory tract infection, nausea, diarrhea, rash, and increased menstrual abnormalities in women.