The EC approval also covers optional digital companion with sensor and app, which provide nhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions
Novartis has secured approval from the European Commission (EC) for its Enerzair Breezhaler (QVM149; indacaterol acetate, glycopyrronium bromide, and mometasone furoate [IND/GLY/MF]) to treat uncontrolled asthma.
Enerzair Breezhaler has been approved as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long‑acting beta2‑agonist (LABA) and a high-dose of an inhaled corticosteroid (ICS) who experienced one or more asthma exacerbations in the previous year.
Once-daily Enerzair Breezhaler is said to be the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination in the EU for the treatment of these patients.
The EC approval is also comprised of an optional digital companion with sensor and app, which offers inhalation confirmation, medication reminders, and access to objective data to better take therapeutic decisions.
The current approval allows marketing the Enerzair Breezhaler in all 27 European Union member states, in addition to the UK, Iceland, Norway, and Liechtenstein.
Enerzair Breezhaler is offered in a transparent capsule, which enables patients to view that they have taken their medication. The drug will be administered through the dose-confirming Breezhaler device, which facilitates once-daily inhalation using a single inhaler.
The sensor is attached to the Breezhaler device and can be linked to the Propeller Health smartphone app
The sensor, which is attached to the Breezhaler device, can be linked to the Propeller Health smartphone app that provides information to the patient for sharing with their physician.
The EC approval was based on efficacy and safety data from more than 3,000 asthma patients in the Phase III IRIDIUM study.
According to the company, the trial showed that the once-daily Enerzair Breezhaler was superior to once-daily Atectura Breezhaler in enhancing the lung function of patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment.
Once-daily Enerzair Breezhaler was already approved in Japan and Canada, while once-daily Atectura Breezhaler has secured approval in the EU as a maintenance treatment of asthma for adults and adolescents 12 years of age and older not adequately controlled with ICS and inhaled short-acting beta2-agonists (SABA), and in Canada and Japan.
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 utilize data and digital offerings to make asthma control an achievable goal for patients and physicians.”
In April this year, Novartis acquired US-based software startup Amblyotech to develop novel digital therapy for children and adult patients with lazy eye.