QVA149 developers Vectura and Sosei have confirmed that Novartis has submitted an application for Japanese approval of the inhaled fixed dose combination of indacaterol maleate and glycopyrronium bromide for the treatment of COPD. Novartis, which licensed the DPI from the two companies, also recently submitted an application for the product in Europe.
Japan approved Seebri glycopyrronium bromide inhalation capsules, and the EC approved the Seebri Breezhaler in September 2012.
Vectura Chief Executive Chris Blackwell commented, “QVA149 continues to make excellent progress with its potential to treat patients suffering from COPD. This disease is progressive and debilitating for sufferers.”
Sosei CEO Shinichi Tamura said, “This Japanese application, following on from the recent QVA149 filing in Europe, marks a further important milestone in the approval process for this innovative once-daily combination therapy which has the potential to be a safe and effective, dual-activity bronchodilator for the treatment of COPD patients.“
Read the Vectura press release.
Read the Sosei press release.
