Novartis has presented more positive late-stage data on its recently-filed chronic obstructive pulmonary disease drug Seebri Breezhaler which showed superior rapid, sustained improvement in lung function and symptom relief over one year compared to placebo.
Results from the Phase III GLOW2 demonstrated that the drug, which was previously-known as NVA237 (glycopyrronium bromide), a long-acting muscarinic antagonist (LAMA), had rapid onset of action at first dose, sustained 24-hour bronchodilation, and was well tolerated over 52 weeks. The results were similar to those observed with Boehringer/Ingelheim/Pfizer's COPD blockbuster Spiriva (tiotropium), while serious adverse events were reported less frequently with glycopyrronium (12.6%) than with either placebo (15.4%) or tiotropium (15.0%).
The treatment, which Novartis licensed from Japan's Sosei and Vectura of the UK in April 2005, was filed in Europe in September last year. A submission in the USA is planned for 2014.
Tim Wright, head of development at Novartis Pharmaceuticals, said the GLOW2 results "affirm the potential for once-daily NVA237 to help patients manage their COPD symptoms and improve their quality of life". He added that the data demonstrate that the drug "could be the second innovative product in our COPD portfolio".
Novartis currently markets Onbrez Breezhaler (indacaterol) a long-acting beta 2-agonist (LABA) in Europe and in March 2012, Novartis launched the 75mcg once-daily dose of the drug in the USA as Arcapta Neohaler. It is also available as a 150 mcg once-daily dose in Japan.