Two COPD therapies from Novartis — Utibron Neohaler (indacaterol/glycopyrrolate) inhalation powder and Seebri Neohaler (glycopyrrolate) inhalation powder — have been approved by the FDA for the long-term maintenance treatment of airflow obstruction in patients with COPD, according to a Novartis announcement.
Utibron Neohaler is a twice-daily fixed-dose combination of the long-acting beta2-adrenergic agonist (LABA) indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg, a long-acting muscarinic antagonist (LAMA). Seebri Neohaler is a twice-daily LAMA glycopyrrolate 15.6 mcg approved as a stand-alone monotherapy .
Novartis expects that both Utibron Neohaler and Seebri Neohaler will be available in the first quarter of 2016. Neither therapy is indicated to treat asthma or sudden symptoms of COPD, the company said.
“With this approval, the COPD community now has a new medicine that can help so many patients by improving not only their symptoms, but also their health-related quality of life. This means the possibility of doing things that matter to them,” said Christi Shaw, US Country Head, President of Novartis Corporation and Novartis Pharmaceuticals Corporation.
The FDA’s decision was based on results of the phase III EXPEDITION trial program, which found Utibron Neohaler demonstrated superior and sustained improvements in lung function at week 12 compared to indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg individually.
More info, including prescribing information, is available on the Novartis website: