FDA Clears New Combo Inhaler, Utibron Neohaler, for COPD

Megan Brooks


October 30, 2015

The US Food and Drug Administration (FDA) has approved a new inhaled combination bronchodilator for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), according to a company news release.

Utibron Neohaler, from Novartis, combines the long-acting beta2-adrenergic agonist indacaterol (27.5 μg) and the long-acting muscarinic antagonist glycopyrrolate (15.6 μg).

In two 12-week efficacy studies, Utibron Neohaler demonstrated "superior and sustained" improvements in lung function at week 12 compared with its individual bronchodilator components, as well as placebo, the company notes in the news release. "Improvements in lung function were seen compared to placebo at 5 minutes after the first dose and sustained through the 12 hour dosing interval."

Utibron Neohaler also led to clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared with placebo.

"I have seen first-hand how this dual bronchodilator provided meaningful symptom improvement to patients, a key objective in COPD management," Donald Mahler, MD, director, Respiratory Services, Valley Regional Hospital, Claremont, New Hampshire, who evaluated Utibron Neohaler in a phase 3 study, said in the news release.

The most common adverse reactions seen in the efficacy studies were sore throat, runny nose, high blood pressure, and back pain.

Utibron Neohaler is taken twice daily and is not indicated to treat asthma or for relief of sudden symptoms of COPD. The company expects Utibron Neohaler to be available in the first quarter of 2016.

The FDA also approved Novartis' single-agent COPD inhaler containing glycopyrrolate inhalation powder 15.6 μg (Seebri Neohaler) as a stand-alone monotherapy for long-term maintenance treatment of airflow obstruction associated with COPD, the company said. Novartis expects Seebri Neohaler will be available in the first quarter of 2016.

Nearly 27 million people in the United States have COPD, which ranks as the third leading cause of death in the country and is a major cause of serious long-term disability.


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