Swiss pharmaceutical firm Novartis has secured the European Commission (EC) approval for Enerzair Breezhaler, along with a digital companion, as a maintenance treatment for asthma.

Enerzair Breezhaler is a long‑acting beta2‑agonist (LABA) and a high-dose of inhaled corticosteroid (ICS), previously approved in Japan and Canada.

The regulatory approval indicated the drug for uncontrolled asthma in patients who experienced one or more asthma exacerbations in the previous year, and the approval is applicable to all 27 European Union member states along with the UK, Iceland, Norway and Liechtenstein.

Novartis Pharmaceuticals global marketing head Rod Wooten said: “Novartis is working to reimagine medicine for people with uncontrolled asthma, who find it a challenge to achieve effective symptom and exacerbation control.

“The approval of Enerzair Breezhaler with sensor and app in the EU is an example of our commitment to utilise data and digital offerings to make asthma control an achievable goal for patients and physicians.”

Novartis developed the digital companion in collaboration with Propeller Health

Enerzair Breezhaler is provided in a transparent capsule that enables patients to visualise their medication and will be administered through the dose-confirming Breezhaler device, which enables once-daily inhalation using a single inhaler.

The approval also includes an optional digital companion with sensor and app that provides inhalation confirmation, medication reminders and access to objective data. The digital companion includes a sensor that attaches to the Breezhaler device and linked to the Propeller Health smartphone app.

The company has developed the digital companion in partnership with Propeller Health, which includes the Propeller Health app and sensor custom-built for the Breezhaler device.

The regulatory approval is supported by the efficacy and safety data from more than 3,000 asthma patients in the Phase 3 IRIDIUM study, in which Enerzair Breezhaler showed positive results compared to Atectura Breezhaler in improving the lung function.

University of Aberdeen primary care respiratory medicine chair David Price said: “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.

“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.”