Novartis announces positive results from asthma combinations

Novartis has announced positive results from trials testing its daily fixed dose treatment two-drug combination for people with uncontrolled asthma, QMF149, and its triple combination QVM149.

Both drugs are under review by the European Medicines Agency after more than a decade of clinical development at Novartis, which acquired rights to QMF149 in 2009 from Schering-Plough.

Novartis and S-P had been collaborating on respiratory drugs since the early noughties and decided to restructure the deal so that the Swiss pharma had rights to QMF149 a few months before the latter’s merger with Merck & Co.

Results from the PALLADIUM and IRIDIUM trials are part of a clinical development programme called PLATINUM, and build on results from the successful QUARTZ study announced earlier this year.

Both trials announced today tested QMF149, a combination of indacaterol acetate and mometasone furoate in patients whose asthma was uncontrolled on standard therapy such as a long-acting beta agonist (LABA) and inhaled corticosteroid (ICS). The new drugs are delivered through Novartis’ dose confirming device known as Breezhaler.

In PALLADIUM QMF149 improved lung function compared with mometasone furoate alone, measured using trough forced expiratory volume in one second (FEV1).

It also improved symptoms assessed with a questionnaire in the 26-week trial, with a statistically significant improvement in asthma control at the end of the study compared with baseline.

IRIDIUM tested a slightly different combination – QVM149, which consists of indacaterol acetate, glycopyrronium bromide and mometasone furoate.

The trial tested QVM149 against QMF149 and found the triple therapy improved FEV1 compared with the two-drug combination, meeting its primary endpoint.

However Novartis said the triple therapy produced a “clinically meaningful” improvement in symptoms measured with the questionnaire, but this was not statistically significant.

Detailed results will be announced at forthcoming medical conferences.

Dr Richard van Zyl-Smit, associate professor, head of the Lung Clinical Research Unit, University of Cape Town Lung Institute, and consultant pulmonologist, Groote Schuur Hospital, Cape Town, South Africa, said: “Promising results from PALLADIUM in both doses of the indacaterol and mometasone furoate combination provide evidence for the efficacy and safety profile of QMF149 for the treatment of asthma.

“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.

Commenting on IRIDIUM, Dr Huib Kerstjens, University Medical Center Groningen, The Netherlands said: “The initial results of IRIDIUM show us that QVM149 can improve lung function in these patients and potentially deliver a substantial reduction in exacerbation rates, which can have a significant impact on the daily lives of people with uncontrolled asthma.”

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