Novartis' asthma triplet beats GSK's Advair in phase 2 trial

Novartis’ triple combination asthma candidate QVM149 has beaten GlaxoSmithKline’s Advair in a phase 2 trial. The study linked QVM149 to statistically significant improvements in lung function, leading Novartis to talk up its potential to improve outcomes in uncontrolled asthma. 

Combining inhaled corticosteroids with long-acting β2-agonists (LABA) has improved asthma care and turned Advair, a product made of salmeterol and fluticasone propionate, into a blockbuster. Advair now faces generic competition, but there remains scope for a branded product that improves on it to rack up significant sales, leading Novartis to tout QVM149 as a potential $1 billion drug.

QVM149, which adds a long-acting muscarinic antagonist to a corticosteroid-LABA backbone, will need to come through ongoing phase 3 trials to deliver on that hype. In the meantime, the Swiss drugmaker is fleshing out the evidence in support of its triplet with data from earlier-phase trials.  

Novartis arrived at the 2019 annual international congress of the American Thoracic Society with data from two phase 2 trials designed to bolster its case for QVM149. The larger of the two trials tested two doses of the Novartis triplet, delivered once daily by the Breezhaler inhalation device already used in chronic obstructive pulmonary disease, against a twice-daily version of Advair.

The trial linked both doses of QVM149 to statistically significant improvements in lung function at a range of time points, resulting in successes against the primary endpoint and secondary objectives. Novartis thinks the data on the bronchodilatory effect of QVM149 will augment its phase 3 results. 

Novartis’ second trial assessed whether the effect of QVM149 varies depending on the time of day it is administered. QVM149 outperformed placebo regardless of whether it was administered in the morning or evening.

With the safety and tolerability results coming in clean, Novartis thinks the data move it a step closer to establishing QVM149 as a once-daily treatment option for the one-third of asthma patients who are poorly served by existing therapies. If the phase 3 trials confirm the results seen to date, Novartis aims to introduce the product in 2020 and turn it into a blockbuster in the coming years.