Novartis receives EC approval for Enerzair Breezhaler, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU - Seite 2

Enerzair Breezhaler is provided in a transparent capsule that allows patients to see that they have taken their medication and will be administered via the dose-confirming Breezhaler device, which enables once-daily inhalation using a single inhaler. The digital companion includes a sensor that attaches to the Breezhaler device and can be linked to the Propeller Health smartphone app, providing patients with inhalation confirmation, medication reminders and access to objective data that can be shared with their physician in order to help them make better therapeutic decisions.

“Today, over 45% of asthma patients at GINA Steps 4 and 5 remain uncontrolled, demonstrating the need for new treatments, delivery approaches and patient support to ensure that medication is taken correctly and treatment goals are reached,” said Professor David Price, Chair of Primary Care Respiratory Medicine, University of Aberdeen. “Once-daily Enerzair Breezhaler plus a digital companion could help to facilitate greater collaborative disease management between physicians and patients in the EU whose asthma remains uncontrolled, despite LABA/ICS treatment.”

The EC approval is based on robust efficacy and safety data from over 3,000 asthma patients in the Phase III IRIDIUM study, in which once-daily Enerzair Breezhaler was superior to once-daily Atectura Breezhaler (QMF149; IND/MF) in improving the lung function of patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment². In the IRIDIUM study, the key secondary endpoint was improvement in the Asthma Control Questionnaire score (ACQ-7) for Enerzair Breezhaler versus Atectura Breezhaler². Both treatments delivered clinically meaningful improvements in this measure of symptoms from baseline at Week 26, but the key secondary endpoint was not met². Among other secondary analyses, IRIDIUM explored asthma exacerbation rates, where statistically significant reductions were observed in moderate-to-severe and severe asthma exacerbation rates with Enerzair Breezhaler compared with an established LABA/ICS standard-of-care (twice-daily salmeterol xinafoate/fluticasone propionate [Sal/Flu])². Safety findings were consistent with the known safety profiles of the monocomponents².