Novartis Reports Results of Enerzair Breezhaler (QVM149) in P-IIIb ARGON Study to Treat Uncontrolled Asthma
Shots:
- The P-IIIb ARGON study involves assessing of IND/GLY/MF (150/50/80 μg - 150/50/160 μg- qd) with Sal/Flu (50/500μg- bid) delivered via Diskus + tiotropium (5 μg)- delivered via Respimat in 1251 patients in a ratio (1:1:1) aged ≥18yrs. with uncontrolled asthma
- The study resulted in meeting its 1EPs demonstrating non-inferiority in change AQLQ. 2EPS include improvements in lung function- asthma control- health status- and a reduction in moderate exacerbations
- IND/GLY/MF has received CHMP’s positive opinion- based on IRIDIUM study and is currently under regulatory review in multiple countries including Switzerland and Japan. IND/GLY/MF will be available in the Breezhaler device which is hydrofluoroalkane/chlorofluorocarbon (HFA/CFC)-free
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