FDA Approves Pair of Novartis COPD Treatments

Drugs are delivered via the low-resistance Neohaler inhaler.

The FDA has approved 2 Novartis inhalation powders for the treatment of chronic obstructive pulmonary disease (COPD).

The manufacturer’s indacaterol/glycopyrrolate inhalation powder (Utibron Neohaler) is indicated for the long-term maintenance treatment of COPD, while its glycopyrrolate inhalation powder (Seebri Neohaler) is approved for use as a stand-alone COPD monotherapy.

Both drugs are delivered via the low-resistance Neohaler inhaler, allowing them to be more easily administered by patients with different severities of airflow limitation.

The approval of Utibron Neohaler was based on data from phase 3 studies in which the drug’s safety and efficacy were examined in a total of 2654 patients with COPD. In one trial, the twice-daily use of Ultibron Neohaler yielded superior and sustained improvements in lung function at week 12 compared with its individual components, indacaterol and glycopyrrolate, as well as placebo.

Improvements in lung function were observed 5 minutes after the first dose, with this effect lasting throughout the entire 12hour dosing interval. The drug also demonstrated clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared with placebo.

“Patients have told us about the tremendous impact their COPD can have on everyday activities," said Novartis president Christi Shaw in a press release. “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.”

The most common adverse events reported by trial participants treated with Utlibron Neohaler include sore throat, runny nose, high blood pressure, and back pain. The drug is not indicated for asthma and should not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms.

Novartis plans to launch both Utibron and Seebri in the first quarter of 2016.