Sosei Group Corporation has submitted an application for the registration of QVA149, an investigational fixed dose combination of two long-acting inhaled bronchodilators (indacaterol maleate and glycopyrronium bromide), as a once-daily treatment for COPD in Japan.
“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,” said Shinichi Tamura, CEO of Sosei.
The application for QVA149 was filed to the European Medicines Agency in October 2012 and the US application is planned for 2014.
