Novartis receives CHMP positive opinion for Enerzair Breezhaler (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma
- CHMP positive opinion advances efforts to provide first-in-class LABA/LAMA/ICS combination for patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment in the EU.?
- Digital companion with app and sensor that provide inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions also covered by positive opinion for Enerzair??Breezhaler??(QVM149; IND/GLY/MF).
- Decision supported by robust efficacy and safety data from over 3,000 patients with asthma in Phase III IRIDIUM study, in which once-daily IND/GLY/MF demonstrated statistically significant improvements in lung function compared with once-daily IND/MF (QMF149).1
- In secondary analyses of the Phase III IRIDIUM study, statistically significant improvements in lung function and reductions in moderate-to-severe and severe asthma exacerbation rates were observed with high-dose IND/GLY/MF compared to high-dose Sal/Flu.1
- IND/GLY/MF 150/50/80 ?g (once-daily)
- IND/GLY/MF 150/50/160 ?g (once-daily)
- IND/MF 150/160 ?g (once-daily)
- IND/MF 150/320 ?g (once-daily)
- Sal/Flu 50/500 ?g (twice-daily, via Accuhaler?)
- IND/GLY/MF 150/50/80 ?g (once-daily)
- IND/GLY/MF 150/50/160 ?g (once-daily)
- Open label Sal/Flu 50/500 ?g (twice-daily) delivered via Diskus??plus tiotropium delivered via Respimat?
- To evaluate efficacy of high-dose IND/GLY/MF and medium-dose IND/GLY/MF compared with Sal/Flu plus tiotropium based on trough FEV1?after 24 weeks of treatment
- To evaluate efficacy of high-dose IND/GLY/MF and medium-dose IND/GLY/MF compared with Sal/Flu plus tiotropium based on Asthma Quality of Life Questionnaire over 24 weeks of treatment.
- To evaluate efficacy of high-dose IND/GLY/MF and medium-dose IND/GLY/MF compared with Sal/Flu plus tiotropium based on ACQ-7 over 24 weeks of treatment.
- To evaluate efficacy of high-dose IND/GLY/MF and medium-dose IND/GLY/MF compared with Sal/Flu plus tiotropium based on lung function over 24 weeks of treatment.
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