Post hoc analysis of Enerzair Breezhaler shows reduction in exacerbation rates of asthma.- Novartis

Novartis announced that high-dose, once-daily Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) significantly reduces both moderate-or-severe and severe asthma exacerbation rates in patients whose asthma is uncontrolled on medium- or high-dose long-acting beta2-agonist (LABA)/inhaled corticosteroids (ICS), when compared with a once-daily medium-dose of the same treatment. The post hoc analysis from the pivotal Phase III IRIDIUM study also showed the safety profile for high-dose Enerzair Breezhaler was in line with previous studies in the Phase III/IIIb PLATINUM clinical development program. The analysis showed high-dose Enerzair Breezhaler (150/50/160 microg) significantly reduced the annualized rate of moderate-or-severe asthma exacerbations by 21% (p=0.026) and severe exacerbations by 31% (p=0.003) in asthma patients not adequately controlled on current inhaled therapies, compared with medium-dose (150/50/80 microg) over 52 weeks. High-dose Enerzair Breezhaler also reduced the annualized rate of all exacerbations (mild, moderate and severe) by 14% (p=0.132) compared with medium-dose, but this finding was not statistically significant. Both doses tested presented with a favorable safety and tolerability profile. Results were presented virtually at the European Respiratory Society (ERS) International Congress 2020.This post hoc analysis supports the potential of high-dose IND/GLY/MF as an effective step-up treatment option to further reduce asthma exacerbations in patients with uncontrolled asthma and complement the efficacy and safety data from the pivotal IRIDIUM study, which indicated the potential of high-dose IND/GLY/MF to improve lung function and reduce exacerbations compared with salmeterol xinafoate/fluticasone propionate standard-of-care.