Novartis drums up anticipation for blockbuster-to-be with PhII data on asthma drug, beating Advair in head-to-head
An asthma drug that Novartis has tapped as a big moneymaker has delivered a clean sweep in Phase II, boosting its blockbuster case months ahead of a Phase III readout.
The two studies compared QVM149 to GlaxoSmithKline’s Advair and placebo, respectively. Results suggest that the inhaled triple — indacaterol acetate, glycopyrronium bromide and mometasone furoate delivered with the Breezhaler device — beat both in improving lung function, as captured by variations of the forced expiratory volume in 1 second (FEV1) metric.
Advair, a blockbuster that has brought in billions in annual sales, is the standard of care in this indication. But it’s also off-patent and recently faced its first generic competitor from Mylan.
In that study (CQVM149B2208), both once-daily doses of QVM149 notched statistically significant improvements of peak FEV1 compared to twice-daily salmeterol/fluticasone propionate “ with mean differences of 172 mL (95% CI: 137, 208) and 159 mL (95% CI: 123, 195), respectively (p<0.001).”
Meanwhile in CQVM149B2209, investigators found that the treatment maintained the same 24-hour benefit whether it was administered in the morning or evening — potentially significant as asthma symptoms tend to be worse at night and the wee hours. Mean differences in FEV1 over 14 days versus placebo were 610 mL (90% CI: 538, 681) and 615 mL (90% CI: 544, 687) for the two doses tested.
“Despite the availability of numerous asthma treatments, more than one-third of asthma patients remain uncontrolled and continue to experience symptoms and/or exacerbations,” said Linda Armstrong, who leads Novartis’ respiratory development unit.
QVM149 combines a long-acting beta agonist, or LABA, with a long-acting muscarinic receptor antagonists (LAMA), packed together with an inhaled corticosteroid and a device that Novartis has used for COPD.
The drug is the only respiratory product among the 14 blockbuster launches that CEO Vas Narasimhan outlined in the beginning of the year. The Phase III trial — which includes 1251 patients compared to 154 total in these two studies — expected to complete later in 2019, with commercialization planned in 2020 if all goes well.
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