Sunovion Pharmaceuticals Inc today announced that Utibron™Neohaler® (indacaterol/glycopyrrolate) inhalation powder is now available at pharmacies in the United States for the long-term maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. UTIBRON NEOHALER is not indicated to treat asthma or for the relief of sudden symptoms of COPD.
UTIBRON NEOHALER is a twice-daily combination long-acting beta agonist and long-acting muscarinic antagonist (LABA/LAMA). Sunovion entered into an exclusive license agreement with Novartis for the U.S. commercialization rights to UTIBRON NEOHALER, as well as Seebri™ Neohaler® and Arcapta® Neohaler®, on December 21, 2016. Novartis received approval from the U.S. Food and Drug Administration (FDA) for UTIBRON NEOHALER in October 2015.
“Sunovion is pleased to bring to market UTIBRON NEOHALER, an important dual-bronchodilator handheld inhaler, that is a new combination therapy now available for the millions of people with COPD in the United States,” said David Frawley, Executive Vice President and Chief Commercial Officer at Sunovion. “As part of our commitment to people living with COPD, Sunovion has built a broad COPD portfolio including nebulized and handheld treatment options for patients at various stages of COPD.”
In clinical studies, UTIBRON NEOHALER demonstrated significantly improved lung function compared to either of its single bronchodilator components (indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg) as well as placebo. Peak improvement in lung function as measured by FEV1 (forced expiratory volume in one second) within four hours after morning dose from baseline was 290 mL and 260 mL in the two 12 week, Phase 3 pivotal studies. Median time to onset of action as defined as 100 mL improvement in FEV1 was seen 12 to 16 minutes after the first dose and was maintained throughout the 12 hour dosing interval in the two pivotal studies. UTIBRON NEOHALER also improved overall quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ) total score, reduced COPD rescue medication use and improved breathlessness as measured by the Transitional Dyspnea Index (TDI) total score in patients as compared to placebo. UTIBRON NEOHALER’s safety profile was similar to its individual components and placebo in clinical trials. The most common adverse reactions (≥2% and higher than placebo) were nasopharyngitis and hypertension.
“UTIBRON NEOHALER is well aligned with the recently updated global treatment strategy for COPD, which emphasizes the use of a LAMA/LABA combination for maintenance treatment in the majority of symptomatic COPD patients,” said Gary Ferguson, M.D., Pulmonary Research Institute of Southeast Michigan, Livonia, Michigan. “Additionally, the NEOHALER device allows patients to visualize whether their dose was administered giving them the flexibility to inhale any remaining dose not fully administered. The ability to provide dosing feedback is an important feature for patients and their health care providers.”
Additional medical information, patient assistance and other information about UTIBRON NEOHALER is available through Sunovion Answers at www.utibron.com or by calling 1-844-276-8262 Monday through Friday from 8 a.m. to 8 p.m. ET.
Sunovion expects to launch SEEBRI NEOHALER, which was approved by the FDA in 2015, and begin promotion of ARCAPTA NEOHALER, which was launched in the U.S. in 2012, in the U.S. during fiscal year 2017 (April 2017-March 2018).