European CHMP recommends approval of Enerzair Breezhaler (indacaterol, glycopyrronium, mometasone) for maintenance treatment of asthma in adults

Enerzair Breezhaler will be available as an inhalation powder in hard capsules. It is intended for use in adults inadequately controlled with maintenance long‑acting beta2‑agonist and high-dose inhaled corticosteroid who experienced ≥1 exacerbation in the previous year.

SPS commentary:

A related press release notes that this is the first asthma triple combination therapy. It will be available with an optional electronic sensor, which is attached to the base of the inhaler and will send data on its use to an app on a smart phone or other suitable device.

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.


European Medicines Agency

Resource links:

Press release

Zimbus Breezhaler opinion