Novartis Receives EC Approval for Enerzair® Breezhaler®, the First Once-Daily LABA/LAMA/ICS Triple Therapy for Uncontrolled Asthma in the EU, Outperforming Salmeterol/Fluticasone (Advair)

July 08, 2020 News /BioValleyBIOON/ --Novartis(Novartis) recently announced that the European Commission (EC) has approved Enerzair Breezhaler (QVM149; indacaterol acetate/glycopyrronium bromide/mometasone furoate; IND/GLY/MF) as a maintenance therapy for patients whose condition is not adequately controlled with a maintenance regimen of a long-acting β2-agonist (LABA) and high-dose inhaled corticosteroid (ICS) combination, and who have experienced one or more asthma exacerbations in the previous year.AsthmaAdult patients. This approval also includes the first digital companion (sensor and app), providing inhalation confirmation, medication reminders, and access to objective data to better support treatment decisions. The EC’s approval decision applies to all 27 EU member states, as well as the UK, Iceland, Norway, and Liechtenstein.

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]). It 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, enabling once-daily inhalation therapy via a single inhaler.

Notably, Enerzair Breezhaler is the first once-daily fixed-dose combination of LABA/LAMA/ICS approved in Europe, and also the first in the European Union that can be prescribed 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.

This approval is based on the Phase III IRIDIUM study involving more than 3,000 patientsAsthmaEfficacy and safety data in patients. The study demonstrated that treatment with Enerzair Breezhaler resulted in statistically significant improvements in lung function compared to Atectura Breezhaler (QMF149, IND/MF, indacaterol acetate/mometasone furoate).

In this study, the key secondary endpoint was the comparison of Enerzair Breezhaler versus Atectura Breezhaler in terms of improvement in Asthma Control Questionnaire (ACQ-7) scores. The data showed that at Week 26 of treatment, both regimens achieved clinically meaningful improvements from baseline in this metric, 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 [Advair, Seretide], twice daily), treatment with Enerzair Breezhaler 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 drug.

Currently, once-daily Enerzair Breezhaler (IND/GLY/MF) has been approved in Japan and Canada. Once-daily Atectura Breezhaler (IND/MF), a fixed-dose combination of LABA/ICS, has been approved in the European Union, Japan, and Canada as maintenance therapy for adult and adolescent asthma patients aged ≥12 years whose condition is not adequately controlled with inhaled corticosteroids (ICS) and short-acting beta-agonists (SABA).

Novartis is committed to bringing Enerzair Breezhaler (IND/GLY/MF) and Atectura Breezhaler (IND/MF) to patients worldwide. These two products are currently undergoing regulatory review in multiple countries, including Switzerland. As part of Novartis’s ongoing commitment to reducing the environmental impact of its asthma portfolio, both products will be administered via the Breezhaler® device, which does not use hydrofluoroalkanes/chlorofluorocarbons (HFA/CFC).

Rod Wooten, Global Head of Marketing at Novartis, stated: “Patients with uncontrolled asthma face significant challenges in achieving effective symptom control and preventing acute exacerbations. The approval of Enerzair Breezhaler and its digital companion in the European Union exemplifies our commitment to leveraging data and digital solutions to make asthma control an attainable goal for both patients and physicians.”

Professor David Price, Head of the Primary Care Respiratory Medicine Department at the University of Aberdeen in the UK, stated, “Currently, over 45% of asthma patients in GINA stages 4 and 5 remain uncontrolled, indicating the need for new medications, delivery methods, and patient support to ensure proper medication adherence and achievement of treatment goals. Once-daily Enerzair Breezhaler, combined with a digital companion, can facilitate better collaboration between physicians in the European Union and asthma patients whose condition remains uncontrolled despite LABA/ICS therapy, thereby enhancing disease management.” (Bioon.com)

Original Source:Novartis receives EC approval for Enerzair® Breezhaler®, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU