Novartis has announced results from the Phase 3b ARGON study of Enerzair Breezhaler (QVM149) indacaterol/glycopyrronium/mometasone for the treatment of uncontrolled asthma, with the data published in the journal Respiratory Medicine. The 24-week study met its primary endpoint, demonstrating non-inferiority of high and medium doses of once-daily Enerzair Breezhaler to twice daily salmeterol xinafoate/fluticasone propionate plus once-daily tiotropium, as well as a number of secondary endpoints.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recently recommended approval of Enerzair Breezhaler for the treatment of uncontrolled asthma. According to Novartis, a number of other regulatory agencies are reviewing marketing applications for the DPI, including Switzerland and Japan.
Novartis Respiratory Global Program Head Dominic Brittain commented, “Novartis is reimagining respiratory medicine by developing innovative, patient-focused medicines such as IND/GLY/MF that address areas of significant unmet clinical need and improve symptom control and quality of life for people with asthma. The ARGON study results show the potential benefits of this once-daily, single inhaler, LABA/LAMA/ICS treatment option in patients with uncontrolled asthma. These data build on the clinically meaningful improvements in lung function and reduction of exacerbations observed for high-dose IND/GLY/MF in the IRIDIUM study.”
Sosei Heptares, which is partnered with Novartis and Vectura on QVM149, issued a separate announcement. Sosei Heptares President and CEO Shinichi Tamura said, “The results from the ARGON Phase 3b study add to the extensive clinical data that Novartis has generated with once-daily IND/GLY/MF. These data show the potential of this novel combination product as an effective and convenient therapy in patients with uncontrolled asthma. We look forward to the final decision by the EC and other Health Authorities on the potential first approvals of once-daily IND/GLY/MF in the weeks ahead.”
Read the Novartis press release.
Read the Sosei Heptares press release.
