Utibron Neohaler (indacaterol/glycopyrrolate) inhalation powder is now available at pharmacies in the United States for the long-term maintenance treatment of airflow obstruction in COPD patients, according to Sunovion Pharmaceuticals Inc. The product, which is manufactered by Novartis, is a twice-daily combination LABA/LAMA.
Utibron Neohaler, which was granted FDA approval in October 2015, is not indicated to treat asthma or for the relief of sudden symptoms of COPD, Sunovion noted.
“Sunovion is pleased to bring to market Utibron Neohaler, an important dual-bronchodilator handheld inhaler, that is a new combination therapy now available for the millions of people with COPD in the United States,” said David Frawley, executive vice president and chief commercial officer at Sunovion.
In clinical studies, the product demonstrated significantly improved lung function compared to either of its single bronchodilator components (indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg) as well as placebo. Peak improvement in lung function as measured by FEV1 within four hours after morning dose from baseline was 290 mL and 260 mL in the two 12 week, Phase 3 pivotal studies.
Sunovion entered into an exclusive license agreement with Novartis for the US commercialization rights to Utibron Neohaler, as well as Seebri Neohaler and Arcapta Neohaler, in December 2016. Sunovion expects to launch Seebri Neohaler and begin promotion of Arcapta Neohaler in the US by March 2018.
More info, including safety information, is available here.