Novartis has announced that the Phase 3 QUARTZ study met its primary and secondary endpoints, demonstrating that low dose QMF149 indacaterol/mometasone furoate delivered via the Breezhaler DPI produced statistically significant and clinically meaningful lung function and asthma control improvements compared to mometasone furoate alone in adult and adolescent patients with inadequately controlled asthma.
The QUARTZ study is part of the Phase 3 PLATINUM development program for both the QMF149 and QVM149 indacaterol/glycopyrronium/mometasone furoate DPIs. Vectura and Sosei recently revealed that Novartis has already filed an MAA for QVM149.
Novartis Respiratory Development Unit Head Linda Armstrong commented, “Despite the number of available treatments, many patients’ lives remain impacted by their asthma. The QMF149 results of the QUARTZ study complement the recently presented Phase 2 data of QVM149 at the 2019 American Thoracic Society Congress, showing superiority of QVM149 to the current standard of care. We look forward to seeing the rest of the data from the PLATINUM clinical trial program.”
Oliver Kornmann, Pulmonary Department, Internal Medicine, University Hospital Mainz, added, “I am very pleased with the results of the QUARTZ study looking at the efficacy and safety of the fixed dose combination of indacaterol and mometasone furoate. Fixed-dose combination inhalers may offer advantages to people with asthma by simplifying complex inhaler regimens, especially when they can be dosed once daily which can therefore further reduce the burden of the disease.”
Read the Novartis press release.
