Novartis has announced that its Ultibro Breezhaler indacaterol/glycopyrronium DPI (QVA149) has gotten a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of COPD. The company filed an MAA for the product in October 2012.
Novartis Division Head David Epstein commented, “The CHMP’s positive opinion supports a major breakthrough in the treatment of COPD, where many patients do not have adequate treatment options. QVA149 has shown significant improvements compared with some of the most commonly used treatment options for COPD, which is projected to be the third leading cause of death by 2020.”
The company reiterated that it plans to file an NDA for QVA149 in the US by the end of 2014. An application for QVA149 was submitted in Japan in November 2012.
Read the Novartis press release.
