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

發(fā)布時間： 2020-07-10 閱讀：777次

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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. 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.”

“Today, over 45% of asthma patients at GINA Steps 4 and 5 remain uncontrolled, demonstrating the need for new treatments, delivery approaches and patient support to ensure that medication is taken correctly and treatment goals are reached,” said Professor David Price, Chair of Primary Care Respiratory Medicine, University of Aberdeen. “Once-daily Enerzair Breezhaler plus a digital companion could help to facilitate greater collaborative disease management between physicians and patients in the EU whose asthma remains uncontrolled, despite LABA/ICS treatment.”