Novartis has announced positive late-stage results from both its combination therapies, QVM149 (indacaterol acetate/glycopyrronium bromide/mometasone furoate) and QMF149 (indacaterol acetate/mometasone furoate), in uncontrolled asthma.
The company announced that the two Phase III studies demonstrated superior improvement in lung function, meeting the trial’s primary endpoints. It also reminded that marketing applications for QVM149 and QMF149, which are both delivered once-daily via the Breezhaler device, are currently being reviewed by the European Medicines Agency.
IRIDIUM, the first trial, was designed to assess the efficacy of medium and high doses of QVM149 and QMF149 versus twice-daily doses of GlaxoSmithKline's Advair (salmeterol/fluticasone). The trial consisted of around 3092 patients with uncontrolled asthma despite medium or high doses of the combination of a long-acting beta-agonist (LABA) and inhaled corticosteroid (ICS), and found that QVM149 was superior to QMF149 in improving trough forced expiratory volume in one second (FEV1) after 26 weeks.
The news “represents a key milestone in the ongoing Novartis effort to reimagine asthma care for patients,” said Linda Armstrong, respiratory development unit head, Novartis Pharmaceuticals.
She continued, “These positive initial IRIDIUM results are consistent with the Phase II outcomes presented at ATS earlier this year and strengthen the evidence to suggest that, if approved, medium and high dose QVM149 could be beneficial for people with asthma who are still uncontrolled after being treated with medium and high dose LABA/ICS.”
Patients with asthma who have poor symptom control or frequent exacerbations despite current therapy may be considered uncontrolled. Despite current therapy, over 40% of patients with asthma at GINA Step 3, and over 45% at GINA Steps 4 and 5 remain uncontrolled, with patients often downplaying or underestimating the severity of their disease, meaning that they are at a higher risk of exacerbation, hospitalisation or death.