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     175  0 Kommentare 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

    • European Commission approves once-daily Enerzair Breezhaler (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS1*
       
    • Optional digital companion with sensor and app that provide inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions also covered by EC approval
       
    • Approval based on robust efficacy and safety data from the Phase III IRIDIUM study, in which once-daily Enerzair Breezhaler was superior to once-daily Atectura Breezhaler (IND/MF) in improving the lung function of patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment2
       
    • Asthma affects an estimated 358 million people worldwide and can cause a significant personal, health and financial burden when not adequately controlled3,4

    Basel, July 7, 2020 — Novartis today announced that the European Commission (EC) has approved Enerzair Breezhaler (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) 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. Once-daily Enerzair Breezhaler is the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination available in the EU for these patients. The approval also includes an optional digital companion with sensor and app that provides inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions. The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

    “Novartis is working to reimagine medicine for people with uncontrolled asthma, who find it a challenge to achieve effective symptom and exacerbation control,” said Rod Wooten, Head of Global Marketing, Novartis Pharmaceuticals. “The approval of Enerzair Breezhaler with sensor and app in the EU is an example of our commitment to utilize data and digital offerings to make asthma control an achievable goal for patients and physicians.”

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    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 European Commission approves once-daily Enerzair Breezhaler (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS1* Optional digital companion with sensor and …

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