Novartis receives CHMP positive opinion for Enerzair® Breezehaler® (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma

Novartis has announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of its Enerzair® Breezehaler® as a maintenance treatment of asthma in adult patients not adequately controlled with currently recommended maintenance drugs who experienced one or more asthma exacerbations in the previous year. The European Commission (EC) reviews the CHMP recommendation and usually delivers its final decision in about two months.

If approved, Novartis’s new medication will be the first asthma treatment in the EU that can be prescribed together with a digital companion—a Propeller Health sensor and app custom-built for the Breezehaler device. The Propeller Health app will provide patients with inhalation confirmation, medication reminders, and access to objective data tat can be shared with their physician.

The CHMP recommendation is based on efficacy and safety data from more than 3,000 patients with asthma from Novartis’s Phase III IRIDIUM study, in which the new medication demonstrated statistically significant lung function improvement as compared with currently recommended asthma control medications.

The sensor for the Breezehaler device was made by Propeller Health and is a CE marketed Medical Device, designed and licensed to Novartis exclusively for use with the Breezehaler inhaler worldwide. The sensor does not alter the drug delivery characteristics of the inhaler itself, but produces a recording of each administered dose. Based on the patient’s recorded medication usage, the app presents personalized content to help the patient better self-manage their asthma.

Read the full press release here.