Shots:

• The approval is based on P-III IRIDIUM study assessing Enerzair Breezhaler (qd) vs Atectura Breezhaler (QMF149; IND/MF) in 3092 patients in the ratio (1:1:1:1) whose asthma is uncontrolled with LABA/ICS SOC treatment which resulted in improvement of ACQ-7 score @26wks.- reductions in asthma exacerbation rates were observed in moderate-to-severe and safety profile was consistent
• Novartis and Propeller Health developed optional digital companion which includes Propeller Health app and sensor custom-built for Breezhaler device enabled with a microchip- a microphone- Bluetooth capabilities- an antenna- and a battery and it has received CE mark
• Enerzair Breezhaler (QVM149- IND/GLY/MF) 150/50/160 μg is a combination of bronchodilation of indacaterol acetate (a LABA) and glycopyrronium bromide (a LAMA) with mometasone furoate (ICS) delivered using dose confirming Breezhaler device available in all 27 EU member states including as the UK- Iceland- Norway and Liechtenstein and also approved in Japan and Canada

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