The European Medicines Agency (EMA) has approved Enerzair Breezhaler, the first triple combination asthma therapy.
The treatment consists of a fixed dose combination of indacaterol, glycopyrronium and mometasone furoate in capsules, to be administered using an inhaler. An optional electronic sensor may also be co-packed with the product. The sensor attaches to the base of the inhaler to collect data on the use of the inhaler by the patient. The sensor will then send the data to an app on a smart phone or other suitable device.
Enerzair Breezhaler is indicated for adult patients whose symptoms are not adequately controlled with a maintenance combination of a long-acting beta-2-agonist and a high dose of an inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. It is a long-term treatment aimed at symptom control by preventing exacerbations and preserving lung function.
The safety and efficacy of Enerzair Breezhaler in adult patients with persistent asthma was evaluated in a phase 3 randomised, double blind study which showed clinically meaningful improvements in lung function and a reduction in exacerbations. The main adverse events observed in the study were asthma exacerbation, nasopharyngitis, upper respiratory tract infection, and headache.