Novartis posts more phase 3 data as EMA reviews asthma combo

Novartis
QMF149, a combination of an inhaled corticosteroid and a long-acting beta agonist is under review by the European Medicines Agency. (Novartis)

Novartis’ asthma combo already beat an inhaled corticosteroid at improving lung function, meeting the primary endpoint in a phase 3 study. Now, the Big Pharma is unveiling yet more data showing how the treatment fared against the standard of care: a combination of the same types of drugs. 

QMF149 comprises mometasone furoate, an inhaled corticosteroid (ICS) and indacaterol acetate, a long-acting beta agonist (LABA). The idea of combining these classes of drugs is not new—GlaxoSmithKline's Advair and Breo, AstraZeneca’s Symbicort and Merck’s Dulera all contain these ingredients. Some of these combos have been around long enough that they now face generic competition. 

The study involved more than 2,000 patients who were randomized to receive one of two doses of QMF149, the ICS mometasone furoate (MF), or salmeterol xinafoate/fluticasone propionate, the drugs that make up GSK’s Advair and Teva’s copycat med

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RELATED: Novartis chalks up another phase 3 asthma win as approval nears 

After 26 weeks of treatment, the study met its primary endpoint, with patients on QMF149 seeing a statistically significant improvement in lung function over those taking MF, as measured by FEV1, the amount of air a person can exhale in one second after taking a deep breath. The combo also beat MF at improving patients’ asthma control, according to a questionnaire that considers symptoms, use of a rescue inhaler and FEV1. “These positive results were also observed at Week 52,” Novartis said in a statement. 

Though secondary analyses showed that the high dose QMF149 was on par with salmeterol xinafoate/fluticasone, or SFC, at controlling asthma, Novartis’ drug outdid the standard of care at improving FEV1, the measure of lung function. QMF149 patients went more days than SFC patients without needing a rescue inhaler and QMF149 also worked faster than SFC, as shown by FEV1 measurements five minutes after inhaling the treatments on day one, Novartis said. 

RELATED: Novartis' asthma combo tops standard of care in phase 3 

It’s unclear if this performance will be enough to differentiate QMF149 in a crowded field. Novartis is aiming for the patients who struggle to control their asthma even with current treatments. 

“Results from the PALLADIUM trial show that indacaterol and mometasone furoate combined is superior to mometasone furoate alone in improving lung function and asthma control; as well as showing reduction in exacerbation rates in a population of patients whose asthma is uncontrolled on a medium to high dose ICS or a low dose combination of LABA/ICS,” said pulmonologist Dr. Richard van Zyl-Smit, who is also a professor and head of lung clinical research at the University of Cape Town Lung Institute in South Africa, in the statement. “Despite current treatments, we know that around 40-45% of patients with asthma remain uncontrolled... highlighting the need for new treatment options to achieve optimal disease control in these patients.” 

QMF149 is under review by the European Medicines Agency.

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