Novartis and UK group Vectura will be celebrating news that regulators in Europe and Japan have issued green lights for the dual bronchodilator Ultibro Breezhaler for the treatment of COPD, a progressive disease that is expected to be the third leading cause of death by 2020.
In Europe, the European Commission approved once-daily Ultibro Breezhaler (indacaterol 85mcg/glycopyrronium 43mcg, also known as QVA149) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with the condition, which is estimated to affect around 10% of its population.
The Japanese Ministry of Health, Labour and Welfare gave the thumbs up for once-daily Ultibro Inhalation Capsules (glycopyrronium 50mcg/indacaterol 110mcg), delivered through the Breezhaler device, for relief of various symptoms due to airway obstruction in COPD, which affects 5.3 million in the country alone.
According to Novartis, dual bronchodilation with Ultibro Breezhaler "is expected to set a new standard of care in COPD", by combining the efficacy benefits and safety profiles of two of its established treatments - the LABA, Onbrez Breezhaler (indacaterol) and the LAMA Seebri Breezhaler (glycopyrronium bromide).
Approval in both regions comes on the back of data from the Phase III clinical trial program IGNITE, which showed that Ultibro Breezhaler significantly improved lung function versus several current standard treatments, and "significant symptomatic improvements" versus placebo in breathlessness, exercise tolerance, rescue medication use and health-related quality of life, the Swiss drug giant said.
The approval of the product in the European Union triggers a $10 million milestone to the UK's Vectura, which licensed rights to glycopyrronium bromide to Novartis in 2005.