The first three Phase III studies of Novartis’ QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) have met all primary endpoints in patients with chronic obstructive pulmonary disease (COPD).

QVA149 is an investigational inhaled, once-daily, fixed dose combination of the long acting beta2-agonist (LABA) indacaterol, and the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide (NVA237).

The Phase III studies, SHINE, BRIGHT and ENLIGHTEN, are part of the IGNITE programme intended to form the basis for a new drug application (NDA) filing in the treatment of COPD.

SHINE is a 26-week multicentre randomised double-blind parallel-group placebo and active controlled pivotal trial of 2,144 COPD patients designed to evaluate the efficacy in terms of trough forced expiratory volume in one second (FEV1).

The three-week randomised blinded double-dummy multi-centre placebo controlled three-period crossover pivotal BRIGHT trial enrolled 85 patients to determine the effect on exercise tolerance of QVA149.

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ENLIGHTEN is a 52-week multicentre randomised double-blind parallel-group placebo controlled pivotal trial of 339 patients, and investigates the safety and tolerability of QVA149.

In the studies, QVA149 demonstrated superiority in trough FEV1 over once-daily indacaterol or once-daily NVA237, showed better exercise endurance compared to placebo and was also well tolerated, with a safety and tolerability profile similar to placebo.

Novartis Pharmaceuticals development head Tim Wright said that meeting the primary endpoints in the IGNITE Phase III clinical trial programme signals significant progress in establishing the potential of QVA149.

"Novartis is committed to addressing the unmet needs of COPD patients and improving their quality of life by providing innovative medicines and devices," Wright added.

The IGNITE patient registration programme includes the ENLIGHTEN, BRIGHT, SHINE, ILLUMINATE, SPARK, BLAZE and ARISE studies, which are expected to conclude this year in more than 5,700 patients across 42 countries and support planned filings in the EU and Japan.

COPD is a progressive disease associated with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.


Image: The Novartis headquarters in Basel. Photo: -Andrew-.