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FDA approves Utibron Neohaler for COPD
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The FDA has approved a dual combination bronchodilator inhalation powder for long-term maintenance of airflow obstruction in patients with COPD, according to a company press release.
However, the approval of indacaterol/glycopyrrolate (Utibron Neohaler, Novartis) is not indicated to treat asthma or sudden symptoms of COPD.
“As a treating physician, I want my patients with COPD to do as well as they can, but you'd be surprised how many I meet who seem to accept less than that," study investigator Donald A. Mahler, MD, a professor of medicine at the Geisel School of Medicine at Dartmouth College, said in a press release. "I have seen first-hand how this dual bronchodilator provided meaningful symptom improvement to patients, a key objective in COPD management.”
The FDA’s approval stems from the results of the phase 3 EXPEDITION trial program which included 2,654 patients with COPD.
The trial program consisted of two 12-week efficacy studies and one 52-week safety study that indicated the combination of indacaterol/glycopyrrolate demonstrated sustained improvements in lung function — as measured by forced expiratory volume in 1 second — compared to its individual bronchodilator components (indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg), as well as placebo.
The dual combination bronchodilator also demonstrated improvements in health-related quality of life and reduced the use of rescue medication compared with placebo.
The dual combination bronchodilator is expected to be available for commercial use in the first quarter of 2016, according to the release.
Editor's Note: On Nov. 3, we corrected the spelling of indacaterol throughout this article and clarified the nature of the EXPEDITION program. The Editors regret these errors.