Novartis has received a positive CHMP opinion for Enerzair Breezhaler, a potential first-in-class inhaled combination for patients whose asthma remains uncontrolled with standard-of-care treatment.
This three-medication combination will provide LABA/LAMA/IC* treatment in one inhaler, once a day, which has been shown to improve lung function vs dual therapy with a LABA/ ICS combination, which is currently a standard of care regimen.
The CHMP positive opinion also included an app and sensor custom-built for the dose-confirming Breezhaler device.
This digital companion, made up of the app and sensor, provides inhalation confirmation, medication reminders and access to objective data, to better support therapeutic decisions and enhanced adherence.
This is the second CHMP positive opinion for Novartis in respiratory this year and we are moving closer to approval of our first new asthma medicines in almost two decades, with which we are delivering on our commitment to reimagine respiratory care.