Novartis Receives CHMP Positive Opinion for Enerzair® Breezhaler® (QVM149), a First-in-Class Once-Daily LABA/LAMA/ICS Combination Therapy for Uncontrolled Asthma

If approved, Enerzair Breezhaler will become the first once-daily fixed-dose combination product of LABA/LAMA/ICS for the aforementioned patients. The CHMP’s opinion will now be submitted to the European Commission (EC) for review, which typically renders its final decision within two months.

Enerzair Breezhaler is a fixed-dose combination product comprising indacaterol acetate (IND, a long-acting beta2-agonist [LABA]), glycopyrronium bromide (GLY, a long-acting muscarinic antagonist [LAMA]), and mometasone furoate (MF, a high-dose inhaled corticosteroid [ICS]), which precisely combines the bronchodilatory effect of IND, the antimuscarinic effect of GLY, and the anti-inflammatory effect of high-dose ICS.

Enerzair Breezhaler is administered using the Breezhaler device, which features a dose-confirmation mechanism and allows for once-daily inhalation therapy via a single inhaler. If approved, Enerzair Breezhaler will be the first product in the European Union that can be prescribed together with a digital companion (the Propeller Health sensor and app customized for the Breezhaler device).AsthmaTreatment Plan. This digital companion provides patients with inhalation confirmation, medication reminders, and access to objective treatment data, which can be shared with physicians to help them make better treatment decisions.

CHMP’s positive opinion, based on data from more than 3,000 patients in the Phase III IRIDIUM studyAsthmaEfficacy and Safety Data in Patients. The study demonstrated that, compared with indacaterol acetate/mometasone furoate (IND/MF), treatment with IND/GLY/MF resulted in a statistically significant improvement in lung function.。

In this study, the key secondary endpoint was the improvement in Asthma Control Questionnaire (ACQ-7) scores with IND/GLY/MF versus IND/MF. The data showed that at Week 26 of treatment, both regimens achieved clinically meaningful improvements from baseline in this measure, but the key secondary endpoint was not met. In other secondary endpoint analyses, the IRIDIUM study explored asthma exacerbation rates. Compared with an established LABA/ICS standard of care (salmeterol/fluticasone propionate [Seretide], twice daily), IND/GLY/MF treatment reduced moderate-to-severe and severeAsthmaThe rate of acute exacerbations was significantly reduced statistically. The safety results in this study were consistent with the known safety profile of the single-component therapy.

Last month, the CHMP also recommended approval of Atectura® Breezhaler® (QMF149, IND/MF, indacaterol acetate/mometasone furoate), a fixed-dose combination of a long-acting beta2-agonist (LABA) and an inhaled corticosteroid (ICS), as maintenance therapy for adults and adolescents aged ≥12 years whose disease is not adequately controlled with inhaled corticosteroids (ICS) and short-acting beta2-agonists (SABA).AsthmaPatient.

Novartis is committed to bringing IND/GLY/MF and IND/MF to patients, and the company is currently submitting regulatory applications in multiple countries, including Switzerland, Japan, and Canada. AsNovartisReduceAsthmaIn line with the ongoing commitment to environmental impact, both IND/GLY/MF and IND/MF will be administered via the Breezhaler® device, which does not use hydrofluoroalkanes/chlorofluorocarbons (HFA/CFC).

NovartisLinda Armstrong, M.D., Head of Pharmaceutical Respiratory Development, stated: “Today’s announcement marks a key milestone in our reimagining of the asthma care journey by bringing innovative medicines and digital companions to patients with uncontrolled asthma. For those who remain impacted by the disease despite receiving existing inhalation therapies,”Asthma“Once-daily IND/GLY/MF has the potential to improve disease control in patients. Furthermore, we are pleased to provide patients with innovative sensor and app companions to help enhance adherence.”

Professor Huib Kerstjens, Head of the Department of Pulmonary Diseases at the University Medical Center Groningen in the Netherlands, stated: “This represents a significant advancement for patients with asthma. Compared with standard care involving a LABA/ICS combination, IND/GLY/MF has been demonstrated to significantly improve lung function and asthma symptoms. In the secondary endpoint analysis of the Phase III IRIDIUM study, high-dose IND/GLY/MF therapy, compared with high-dose salmeterol/fluticasone propionate (Seretide), resulted in improved outcomes for moderate-to-severeAsthma“The rate of acute exacerbations was significantly reduced.”(Bioon.com)

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