FDA approved the dual combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) and the stand-alone monotherapy Seebri Neohaler (glycopyrrolate) – which is one component of Utibron Neohaler -- for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Novartis paid Vectura Group $22.5 million, its partner in developing the treatments, after the FDA approval. Novartis expects that Utibron Neohaler and Seebri Neohaler (formerly NVA237; glycopyrrolate) will be available in the first quarter of 2016.
“The launches of Novartis’ Ultibro Breezhaler and Seebri Breezhler ex-US have demonstrated the effectiveness of these products and the need for new treatment options for patients with COPD in the U.S.,” said James Ward-Lilley, chief executive of Vectura, in a press release.
Novartis reported $297 million in sales for the 2 products, or 174% growth, in the first 9 months of 2015, according to Ward-Lilley. “Once launched, the products will bring a new royalty stream for Vectura and we look forward to confirmation from our partner in due course on their plans for the commercialization of these products.”
Nearly 27 million people in the United States are affected by COPD, which ranks as the third leading cause of death in the United States, and is a major cause of serious long-term disability.
FDA's decision to approve Utibron Neohaler is based on results of the phase 3 EXPEDITION trial program, which included 2,654 patients with COPD. The trial consisted of two 12-week efficacy studies and one 52-week safety study.
In the efficacy studies, Utibron Neohaler demonstrated superior and sustained improvements in lung function (FEV1 AUC0-12) at week 12, compared to its individual bronchodilator components (indacaterol 27.5 µg and µg glycopyrrolate 15.6 µg as well as placebo, dosed twice daily. 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 showed clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared to placebo.
The most common adverse reactions seen in the efficacy studies (incidence greater than or equal to one percent and higher than placebo) were sore throat, runny nose, high blood pressure and back pain.