Novartis AG's investigational three-drug combination therapy Enerzair Breezhaler was shown to be as effective as existing treatments in improving the quality of life of people with uncontrolled asthma, meeting the main goal of a late-stage study.
The phase 3 trial, dubbed Argon, evaluated medium and high doses of Enerzair Breezhaler — formerly known as QVM149 — an inhaled, once-daily, fixed-dose combination therapy of indacaterol acetate, glycopyrronium bromide and mometasone furoate for individuals with uncontrolled asthma. Mometasone furoate belongs to a class of medicines used to treat asthma called corticosteroids.
In Argon, the Enerzair Breezhaler was compared to a combination of existing asthma treatment salmeterol xinafoate and fluticasone propionate delivered twice a day, plus a once-daily dose of tiotropium, through two different devices.
Patients treated with the Novartis triple combination therapy also experienced improved lung function, asthma control and health status, together with reduced moderate exacerbations after 24 weeks.
Argon is part of the company's late-stage Platinum clinical development program for the Enerzair Breezhaler and a dual indacaterol acetate and mometasone furoate therapy, together with other studies Quartz, Palladium and Iridium. Results of the Argon trial were published online in Respiratory Medicine.
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of Enerzair Breezhaler in May. The drug is also under regulatory review in other countries, including Switzerland and Japan.