Novartis reports positive Phase 3 PALLADIUM results in uncontrolled asthma

pharmafile | September 30, 2019 | News story | Sales and Marketing  

Novartis has announced that its investigational, once-daily, fixed-dose inhaled QMF149 (indacaterol acetate and mometasone furoate) was superior to mometasone furoate (MF) in improving through forced expiratory volume in one second after 26 weeks.

The superior improvement in lung function occurred in patients with asthma who remain uncontrolled on treatment with inhaled corticosteroid (ICS) at medium or high dose, or long-acting bet agonist at low dose.

Dr. Richard van Zyl-Smit, Associate Professor and Head of the Lung Clinical Research Unit, University of Cape Town Lung Institute, said: “Nearly half of all patients with moderate-to-severe asthma remain uncontrolled and continue to suffer with regular symptoms and exacerbations.

“If approved, the easy-to-use, dose-confirming, once-daily device adds an additional and important option for clinicians treating asthma. I believe that this new fixed-dose combination has the potential to improve and simplify the lives of many patients with uncontrolled asthma.”

Key secondary endpoints including improvement in Asthma Control Questionnaire (ACQ-7), were also met for combined doses of IND/MF when compared to combined doses of MF, with a statistically significant improvement of asthma control achieved from baseline at Week 26.

Linda Armstrong, Respiratory Development Unit Head at Novartis, 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.”

Detailed results from the PALLADIUM trial will be presented at upcoming medical congresses.

Nik Kiran

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