Novartis first-in-class once-daily dual bronchodilator Ultibro Breezhaler (QVA149) achieves near simultaneous approval for COPD patients in Europe and Japan

Novartis announced today that the European Commission approved once-daily Ultibro^® Breezhaler^® (indacaterol 85 mcg / glycopyrronium 43 mcg) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).  In addition, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved once-daily Ultibro^® Inhalation Capsules (glycopyrronium 50 mcg / indacaterol 110 mcg), delivered through the Breezhaler^® device, for relief of various symptoms due to airway obstruction in COPD. Ultibro^® Breezhaler^® / Ultibro^® Inhalation Capsules were developed under the name QVA149.

“We are very pleased that the European Commission and Japan approved QVA149, nearly simultaneously, for COPD patients. This rapid approval in Japan reflects our build-up of clinical trial and regulatory capabilities in Japan,” said David Epstein, Division Head, Novartis Pharmaceuticals. “Many COPD patients will now have a better treatment option, including first-line therapy with the launch of Ultibro Breezhaler in Europe.”

Dual bronchodilation with QVA149 is expected to set a new standard of care in COPD by combining the proven efficacy benefits and safety profiles of two established Novartis COPD treatments: the LABA*, Onbrez^® Breezhaler^® (indacaterol); and the LAMA**, Seebri^® Breezhaler^® (glycopyrronium bromide). Both these components are delivered through the Breezhaler^® device, as is QVA149, and are widely available around the world.

The approvals of QVA149 in Europe and Japan were based on the comprehensive IGNITE Phase III clinical trial program, one of the largest international trial programs in COPD comprising 11 studies in total with more than 10,000 patients from 52 countries. From the eight IGNITE studies which completed in 2012, data showed that QVA149 significantly improved lung function versus several current standard treatments and showed significant symptomatic improvements versus placebo in breathlessness, exercise tolerance, rescue medication use and health-related quality of life. QVA149 also demonstrated statistically significant symptomatic improvements in breathlessness, rescue medication use and health-related quality of life compared to open-label (OL) tiotropium 18 mcg¹. The rate of all COPD exacerbations (mild, moderate and severe) was significantly improved with QVA149 compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg³.

“Since 2007, Novartis has received approvals for 15 new treatments and 16 new indications for existing treatments in Japan,” said Timothy Wright, Global Head Development, Novartis Pharmaceuticals. “Japan plays a critical role in our global clinical research program. In the last five years, Novartis has conducted 175 clinical studies in Japan with over 14,000 patients.”

In clinical studies, QVA149 demonstrated an acceptable safety profile with no meaningful differences between the treatment groups (placebo, indacaterol 150 mcg, glycopyrronium 50 mcg, OL tiotropium 18 mcg, salmeterol / fluticasone (SFC) 50 mcg / 500 mcg) in the incidence of adverse and serious adverse events. The safety profile was characterized by typical anticholinergic and beta-adrenergic effects related to the individual components of the combination.

COPD is a progressive disease affecting up to 10% of adults across Europe and is projected to be the third leading cause of death by 2020. In addition, 5.3 million patients are currently living with COPD in Japan.