Novartis phase III COPD studies meet primary endpoints
The first three Novartis Pharmaceuticals QVA149 phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints.
The SHINE, BRIGHT and ENLIGHTEN studies, which are key components of the IGNITE program, demonstrate the potential of QVA149 in the treatment of COPD. The IGNITE program is one of the largest international patient registration programs in COPD comprising 10 studies in total. The first seven studies are expected to complete in 2012 and include more than 5,700 patients across 42 countries and support planned filings in the E.U. and Japan.
SHINE was a multicenter, randomized, double-blind, parallel-group, placebo and active controlled pivotal trial of 2,144 patients with moderate to severe COPD. The trial met its endpoint by demonstrating the superiority in trough FEV1 (p<0.001) of once-daily QVA149 compared to once-daily indacaterol or once-daily NVA237 in patients with moderate to severe COPD. In addition, QVA149 showed superiority in trough FEV1 (p<0.001) compared to placebo and open-label tiotropium (18 mcg).
BRIGHT results confirmed that patients experienced significantly better exercise endurance versus placebo (p=0.006). BRIGHT was a three-week, randomized, blinded, double-dummy, multi-center, placebo controlled, three-period crossover pivotal trial of 85 patients with moderate or severe COPD.
Lastly, ENLIGHTEN demonstrated that QVA149 was well tolerated with a safety and tolerability profile similar to placebo. ENLIGHTEN was a 52-week, multicenter, randomized, double-blind, parallel-group, placebo controlled pivotal trial of 339 patients with moderate or severe COPD.
"Meeting the primary endpoints in the IGNITE phase III clinical trial program signals significant progress in establishing the potential of QVA149, which is expected to be the third innovative medicine in our strong COPD portfolio," said Tim Wright, head of development, Novartis Pharmaceuticals. The two products already in Novartis’ COPD portfolio are Onbrez Breezhaler (indacaterol) and investigational SeebriBreezhaler (glycopyrronium bromide/NVA237).
QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50mcg) 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). Data from the IGNITE clinical trial program examining QVA149 in a number of settings will be submitted for presentation to a major medical congress later this year.