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

If the phase 3 trials confirm the results seen to date, Novartis aims to introduce its asthma product in 2020. (Novartis)

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.  


Lipid-based Formulations for Early Stage Clinical Trials

Liquid-filled capsule technology has a proven record for addressing complex API formulation challenges, but also offers a simple and effective pathway to the clinic. Register now to learn more about lipid-based formulations.

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.  

Suggested Articles

The action will see Kiadis switch its attention to earlier-stage natural killer cell therapies against solid tumors and hematological cancers.

The Weill Family Foundation is stumping up $106 million to create a so-called “Neurohub.”

The takeover centers on TRPML1 agonists designed to treat neurodegenerative disorders by clearing toxic proteins from the brain.