Cipla has announced that a Phase 3 study demonstrated therapeutic equivalence of its generic fluticasone propionate/salmeterol DPI (100/50 mcg) to Advair Diskus 100/50 mcg. The 15-month trial enrolled 1400 asthma patients in the US.
Cipla Global CEO Umang Vohra commented, “I am extremely pleased with the successful completion of the Phase-3 clinical study of generic Advair Diskus. Considering the complexity of clinical endpoint study in the Fluticasone + Salmeterol combination, it is heartening to see that our study was successful in the first attempt. This is an important milestone and is a testament to Cipla’s strong respiratory capabilities and will go a long way in strengthening our respiratory franchise in the US. Unmatched presence across the care continuum and the widest range of drug-device combinations has established Cipla’s position as a lung leader in India and other key emerging markets. Our endeavor is to extend this expertise across developed markets through niche product development.”
Read the Cipla press release.
