Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair Breezhaler (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma

• Once-daily Enerzair Breezhaler (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving quality of life in people with uncontrolled asthma¹.

• Among secondary analyses, improvements in lung function, asthma control, health status, and a reduction in moderate exacerbations were observed with once-daily high-dose IND/GLY/MF compared to a free combination of high-dose Sal/Flu plus Tio¹.
   
• IND/GLY/MF recently received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is currently under regulatory review in multiple countries.
   
• If approved, once-daily IND/GLY/MF will be the first LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS treatment and could provide an effective and convenient alternative to the current standard-of-care regimen.

Basel, June 5, 2020 — Novartis today announced that full results from the Phase IIIb ARGON study were published online in Respiratory Medicine. These results show that once-daily treatment with single inhaler, high- and medium-dose Enerzair Breezhaler (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) demonstrated non-inferiority to a free combination of twice-daily, high-dose salmeterol xinafoate/fluticasone propionate (Sal/Flu) plus once-daily tiotropium (Tio), delivered in two different devices, in improving quality of life in people with uncontrolled asthma¹. Among secondary analyses, improvements in lung function, asthma control, health status, and reductions in moderate exacerbations were observed with high-dose once-daily IND/GLY/MF compared to high-dose Sal/Flu plus Tio¹.

“Today, over 45% of patients at GINA Steps 4 and 5 remain uncontrolled, despite current therapy, demonstrating the need for additional treatment options in this patient population,” said Assistant Professor Christian Gessner, Head of POIS Leipzig Study Centre and Guest Doctor at Universität Leipzig. “The ARGON study shows that once-daily IND/GLY/MF improves quality of life and, if approved, could provide an effective and convenient treatment for patients whose asthma is uncontrolled with LABA/ICS treatment.”