According to Novartis, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Seebri Breezhaler glycopyrronium/NVA237 DPI for the treatment of COPD. Novartis submitted the MAA in September 2011.
“This positive opinion for Seebri Breezhaler is a major milestone in our efforts to offer COPD patients and health care professionals an alternative once-daily therapy in the LAMA class that has the potential to reduce breathlessness, increase the capacity to exercise and help improve quality of life. When approved, Seebri Breezhaler will be the second innovative once-daily inhaled treatment in the growing Novartis COPD portfolio delivered using the low-resistance Breezhaler device that allows patients to hear, feel and see that they have taken the drug correctly,” commented Novartis Division Head David Epstein.
The company reiterated that it expects to file an NDA for Seebri Breezhaler with the FDA in 2014.
Read the Novartis press release.
