Posted by Michael Wonder on 01 May 2020
Novartis receives CHMP positive opinion for Enerzair Breezhaler (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma
1 May 2020 - Digital companion with app and sensor that provide inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions also covered by positive opinion for Enerzair Breezhaler.
Novartis today announced the EMA's CHMP has adopted a positive opinion recommending the approval of Enerzair Breezhaler (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate) 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.
If approved, this will be the first once-daily LABA/long-acting muscarinic antagonist/ICS fixed-dose combination for these patients.
