Data from a 26-week head-to-head Phase 3 study show that the Ultibro Breezhaler indacaterol/glycopyrronium DPI produced greater improvement in the lung function of COPD patients with or without a history of moderate-to-severe exacerbations compared to Seretide Accuhaler (Advair Diskus), Novartis has announced.
The company says that it intends to file a regulatory submission for the product in China that will include this data by the end of 2014. Ultibro was approved in Europe and in Japan in September 2013
Novartis Global Head of Development Tim Wright said, “This is the second time Ultibro Breezhaler has shown superiority in improving lung function to Seretide in a head-to-head study and confirms benefits beyond this current standard of care. Such promising data will be part of a regulatory submission in China later this year and is exciting news for the COPD community and ultimately patients.”
Read the Novartis press release.
