The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Enerzair Breezhaler, the first triple-combination asthma therapy that includes an optional digital sensor.
Enerzair Breezhaler, from Novartis, consists of a fixed-dose combination of three active substances ― the long-acting beta-agonist indacaterol acetate (IND), the muscarinic anticholinergic glycopyrronium bromide (GLY), and the corticosteroid mometasone furoate (MF) ― which are administered using the “dose-confirming” Breezhaler device.
Enerzair Breezhaler is indicated as maintenance asthma therapy for adults whose asthma is not adequately controlled with a maintenance combination of a long-acting beta-2 agonist and a high dose of an inhaled corticosteroid and who have experienced one or more asthma exacerbations during the previous year. It’s taken once daily.
An optional electronic sensor can be attached to the base of the inhaler to collect data on the use of the inhaler by the patient. The data are sent to an app on a smartphone or other suitable device.
The positive CHMP opinion is “a key milestone in our journey to reimagine asthma care by bringing innovative medicines and a digital companion to patients with uncontrolled asthma,” Linda Armstrong, MD, Respiratory Development Unit head, Novartis Pharmaceuticals, said in a news release.
“Once-daily IND/GLY/MF has the potential to improve asthma control for patients whose lives are still impacted by their disease, despite existing inhaled therapies. Additionally, we are pleased to bring an innovative sensor and app companion supplied with IND/GLY/MF to patients to help support enhanced adherence,” she said.
The safety and efficacy of Enerzair Breezhaler for adults patients with persistent asthma were evaluated in a phase 3 randomized, double-blind study involving more than 3000 patients.
Results showed “clinically meaningful improvements in lung function and reduction of exacerbations,” the EMA said in a statement.
The main side effects included asthma exacerbation, nasopharyngitis, upper respiratory tract infection, and headache. The safety and efficacy of Enerzair Breezhaler have not been established in patients younger than 18 years.
The CHMP also adopted a positive opinion for Zimbus Breezhaler (indacaterol, glycopyrronium, and mometasone furoate), which is a duplicate of Enerzair Breezhaler for the treatment of asthma.
The CHMP opinion will now be sent to the European Commission, which will make the final decision on marketing in the European Union.