Combo COPD Rx Coming Soon

Utibron Neohaler (indacaterol/glycopyrrolate), from Novartis, approved to treat COPD

/ Author:  / Reviewed by: Jennifer Gershman, PharmD, CPh

(RxWiki News) A newly approved medication could help the nearly 27 million COPD patients in the US breathe easier.

The US Food and Drug Administration (FDA) recently approved the Utibron Neohaler (indacaterol/glycopyrrolate) to treat patients with chronic obstructive pulmonary disease (COPD). Novartis, which manufactures this drug, stated in a press release that this inhaled, dual combination bronchodilator would likely be available in early 2016.

COPD is a lung disease that makes breathing difficult. It's the third leading cause of death in the US, according to Novartis, and it can be disabling.

"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," said Dr. Donald Mahler, director of respiratory services at Valley Regional Hospital, Claremont, NH, who studied the Utibron Neohaler before it was approved, 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."

In multiple studies, the Utibron Neohaler appeared to improve "health-related quality of life" in COPD patients more than a placebo (fake treatment) and more than either of the drugs it contains alone. Patients taking Utibron were also less likely to need rescue medication — lifesaving drugs used during acute health problems, such as extreme breathing problems — for their COPD. This drug is not a rescue medication.

Indacaterol, one of the components of Utibron, has been tied to an increased risk of death related to asthma. Utibron Neohaler is not indicated for asthma patients. Side effects of Utibron included back pain, sore throat, runny nose and high blood pressure.

The FDA also approved one of Utibron Neohaler's components, glycopyrrolate, by itself to treat COPD patients. This drug was approved under the brand name Seebri Neohaler. Novartis said Seebri will likely be available in early 2016.

Review Date: 
November 3, 2015
Last Updated:
November 4, 2015