Date: 2011-06-29
Type of information: Initiation of preclinical development
phase: 3
Announcement: results
Company: Novartis (Switzerland)
Product: NVA237 (glycopyrronium bromide)
Action mechanism:
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Respiratory diseases
Country:
Trial
details: GLOW2 was a 52-week double-blind, placebo-controlled, parallel-group study involving 1,066 patients to assess the efficacy, safety and tolerability of NVA237 in patients with COPD. Patients were randomized into three treatment arms receiving either once-daily NVA237 50 mcg or placebo (double-blind), or once-daily tiotropium 18 mcg (open label). They were also permitted to use COPD background therapy and rescue medication.
Latest
news: Results from the pivotal Phase III GLOW2 clinical trial show that once-daily NVA237 (glycopyrronium bromide) 50 mcg significantly improved lung function in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) relative to placebo (p<0.001), with similar efficacy to open-label tiotropium.
In an exploratory arm of the study, NVA237 was compared with open-label tiotropium (Spiriva® HandiHaler®*) 18 mcg, another once-daily long-acting muscarinic antagonist (LAMA) indicated for the treatment of COPD. Results show that NVA237 produced similar improvements in lung function to tiotropium.
The study met its primary endpoint by demonstrating superior 24-hour bronchodilation to placebo at 12 weeks measured by trough FEV1 (i.e. forced expiratory volume in one second), a standard measure of lung function. NVA237 was delivered using the Concept1® device, a single-dose dry-powder inhaler.
Key secondary endpoints were improvement in breathlessness assessed using the Transition Dyspnea Index (TDI) at 26 weeks, and improved quality of life as measured by the St George's Respiratory Questionnaire (SGRQ) at 52 weeks. Important secondary endpoints were time to first COPD exacerbation and use of rescue medication during 52 weeks of treatment. The study met all of these endpoints.
The GLOW2 study also showed that NVA237 was well-tolerated with a similar incidence of adverse events for patients treated with NVA237, placebo and open-label tiotropium.
Further efficacy and safety results from GLOW2 will be presented at a scientific congress in 2012, and the data will be used to support an application for regulatory approval to be filed before the end of 2011.
NVA237 was licensed to Novartis in April 2005 by Vectura and its co-development partner, Sosei. Novartis intends to launch NVA237 in 2012 as a once-daily monotherapy for COPD and as a combination with its once-daily, long-acting beta-agonist (LABA), indacaterol, known as QVA149, in 2013. Vectura believes that it could be the first once-daily LAMA/LABA combination to come to market for COPD. The dual activity of a muscarinic antagonist and a beta-adrenergic agonist promises to be a potent bronchodilator and, with convenient once-daily dosing as a co-formulation, has the potential to improve compliance and address a large and unmet need for COPD sufferers.
