Novartis asthma combination therapy Enerzair Breezhaler has been approved by the European Union.

On July 7, local time, Novartis announced that the European Commission (EC) had approved Enerzair Breezhaler (QVM149; Acetate datero/glon bromide/momisson; IND/GLY/MF) as a maintenance therapy for adult asthma patients who receive long-acting beta 2 receptor agonists (LABA) and high-dose inhaled corticosteroids (ICS) combination therapy that did not adequately control the condition and experienced an acute increase in asthma in the previous yearthe approval, making Enerzair Breezhaler the first LABA/LAMA/ICS fixed-dose combination product available in the European Union for this patient populationThe approval also includes digital companion (Propeller Health sensors and applications customized for Breezhaler devices) to assist patients with inhalation confirmation, medication reminders, and access to objective data to better support the customization of treatment decisionsEC approval is based on efficacy and safety data from Phase III clinical trial IRIDIUMThe study, which involved 3,000 asthma patients, showed a statistically significant improvement in lung function compared to IND/MFThe key secondary endpoint of the study was the improvement of the score of ACQ-7 of the asthma control questionnaire, which showed that both treatment options had a clinical improvement in the relative baseline of the indicator for 26 weeks of treatment, but did not reach the expected endpointOther secondary endpoints include an acute asthma attack rate, which Enerzair Breezhaler significantly reduced compared to labA/ICS care standardsThe safety results observed in the study were consistent with known single-component securityAsthma affects about 358 million people worldwide, and based on current treatment conditions, more than 40 percent of patients classified as in Step3, based on the Global Asthma Management and Prevention Strategy Guidelines (GINA), do not have good control of their condition, and more than 45 percent of patients at GINA Step4 and Step5 stages do not have controlUncontrolled asthma patients may not value or underestimate the severity of their disease, leading to increased illness, hospitalization, or greater riskEnerzair Breezhaler is a fixed-dose combination of ACETATE datero (IND, a LABA), GLY, a long-acting toxic alkaloid receptor antagonist (LAMA), and monite (MF, high-dose ICS) combined with GLY's bronchodiulin and high-dose anti-inflammatory actionEnerzair Breezhaler has been approved in Japan and Canada, and Atectura Breezhaler has been approved by the European Union for use in adolescents and adults with asthma who are over 12 years of age, receive ICS and inhale short-acting beta receptor agonists (SABA) that do not adequately control the conditionCurrently, several countries are conducting regulatory reviews of Enerzair Breezhaler and Atectura BreezhalerSource: Novartis Receives EC approval for Enerzair ® Breezhaler ®, the mesz ding the digital first companion (sensor and app) that can can be prescribed longside a treatment for snoisan asthma in the EU.