Novartis has announced that its Phase 3 PALLADIUM trial of QMF149 indacaterol acetate/mometasone furoate (IND/MF) delivered via the Breezhaler DPI in patients with uncontrolled asthma met its primary endpoint, demonstrating superior improvement in lung function after 26 weeks compared to mometasone furoate alone. The company said that its MAA for QMF149 has been accepted for review by the EMA.
The PALLADIUM study compared 150/160 µg and 150/320 µg doses of QMF149 to 400 µg and 800 µg doses of Asmanex Twisthaler or 50/500 µg Seretide Accuhaler in 2216 patients whose asthma was uncontrolled on medium to high doses of ICS or a low dose of LABA/ICS. The study is part of the PLATINUM clinical program evaluating QMF149 and QVM149 indacaterol/glycopyrronium/mometasone furoate.
Novartis Respiratory Development Unit Head Linda Armstrong said, “We are very pleased that PALLADIUM demonstrated the efficacy and safety of medium and high doses of QMF149, delivered via our dose-confirming Breezhaler device. These results complement the findings of the Phase 3 QUARTZ study for a lower dose of QMF149 and provide additional evidence of the benefits of this combination treatment across the full dose range. We look forward to announcing more data from the PLATINUM clinical development program.”
Read the Novartis press release.
