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 function and ACQ-7 score. Both the treatment showed improvement in symptoms @26wks. but 2EPs was not met. In the secondary analyses- therapy showed a reduction in mod.-to-sev. and sev. asthma exacerbation rate with high-dose IND/GLY/MF vs high-dose Sal/Flu
• Novartis is working with multiple regulatory authorities- including Switzerland- Japan and Canada to bring IND/GLY/MF and IND/MF to patients. QVM149 will be administered via the dose confirming Breezhaler device- if approved- it will be the first asthma treatment that can be prescribed together with a digital companion with app and a sensor in the EU

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