Novartis builds case for asthma drugs to challenge GSK

Novartis has positive data for a two-drug asthma regimen that forms the backbone of its efforts to take on rival GlaxoSmithKline in the respiratory market.

The QUARTZ trial of QMF149 – composed of long-acting beta agonist (LABA) indacaterol acetate and inhaled corticosteroid (ICS) mometasone furoate given in a once-daily dose – showed that the two-drug combination performed better than the ICS alone in patients with poorly-controlled asthma.

The duo improved lung function and asthma symptom control better than mometasone alone, giving Novartis the first completed trial in its phase 3 PLATINUM programme for QMF149 and three-drug combination called QVM149 which adds in long-acting muscarinic agonist (LAMA) glycopyrronium bromide.

QUARTZ investigator Oliver Kornmann of University Hospital Mainz in Germany said: “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.

QMF149 achieved statistically significant improvements in terms of trough FEV1 – the volume of air that can be forced out in one second after taking a deep breath measured approximately 24 hours after the last administration of study drug - compared to mometasone monotherapy after 12 weeks of treatment.

QFM149 is one pillar of Novartis’ plans to take on GSK, which dominated the market for asthma and chronic obstructive pulmonary disease (COPD) therapies for years with its Advair (salmeterol/fluticasone) product. The data is however something of a placeholder for the QVM149 triple, viewed as having the bigger commercial potential.

With Advair losing patent protection in some markets and facing generic competition – though only recently in the US – GSK has been working to build a market for its own triple LABA/LAMA/ICS Trelegy (fluticasone furoate/umeclidinium/vilanterol), initially in COPD but now with data in asthma that could set up regulatory filings in the coming months.

Uncontrolled asthma is a smaller market than COPD, but isn’t insignificant as around a third of all asthma patients fall into that category.

Novartis already has data in hand from a phase 2 trial showing that its once-daily triple works better than twice-daily Advair in uncontrolled asthma, achieving significant improvements in lung function and encouraging the company to start thinking about $1 billion-plus sales for the drug if approved.

Trelegy meanwhile has started to gather momentum after a slow start with first-quarter 2019 sales reaching £87 million ($113 million), more than half the £156 million total for 2018 as a whole.

Novartis has already filed both QMF149 and QVM149 for approval in uncontrolled asthma in Europe, setting up possible launches in 2020.