Tags : QVM149

Biotech Clinical Trials

Novartis Reports Results of Enerzair Breezhaler (QVM149) in P-IIIb ARGON

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 […]Read More

Pharma Regulatory

Novartis’ Enerzair Breezhaler (QVM149, IND/GLY/MF) Receives CHMP’s Recommendation for Approval

Shots: The CHMP’s recommendation is based on P-III IRIDIUM study assessing IND/GLY/MF (150/50/160 μg & 150/50/80 μg) vs IND/MF doses (150/320 μg & 150/160 μg) in 3,092 patients in a ratio (1:1:1) with uncontrolled asthma, as determined by pulmonary function testing and effects on asthma control The P-III IRIDIUM study resulted in improvements in lung […]Read More