Press release
Oct 30, 2015

Sosei confirms FDA approvals of new dual combination bronchodilator Utibron Neohaler and monotherapy Seebri™ Neohaler® for patients with chronic obstructive pulmonary disease

  • Approval of Utibron Neohaler brings an important new dual combination bronchodilator option to patients with chronic obstructive pulmonary disease (COPD) 
  • FDA also approves Seebri Neohaler (glycopyrrolate) inhalation powder as a stand-alone monotherapy for COPD 
  • The approvals trigger 22.5 million dollar milestone payments to Sosei
Tokyo, Japan – 30 October 2015: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms today that the US Food and Drug Administration (FDA) has approved the new Novartis dual combination bronchodilator Utibron™ Neohaler® (indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg) inhalation powder for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The FDA also approved Seebri™ Neohaler® (glycopyrrolate) inhalation powder 15.6 mcg – which is one component of Utibron Neohaler – as a stand-alone monotherapy for COPD. Sosei is eligible to receive milestone payments of 22.5 million dollars for approval of both products.
COPD is a progressive and life-threatening lung disease that makes it difficult to breathe1. Nearly 27 million people in the US are affected by COPD2, which ranks as the third leading cause of death in the US3,4 and is a major cause of serious long-term disability5.
Utibron Neohaler and Seebri Neohaler are expected to become available in the first quarter of 2016.
The FDA's decision to approve Utibron Neohaler is based on results of the phase III EXPEDITION trial program, which included 2,654 patients with COPD and consisted of two 12-week efficacy studies (FLIGHT 1 & 2) and one 52-week safety study (FLIGHT 3)6.
In the efficacy studies, Utibron Neohaler demonstrated superior and sustained improvements in lung function (FEV1 AUC0-12)6 at week 12, compared to its individual bronchodilator components (indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg) as well as placebo, all dosed twice-daily6. Improvements in lung function were seen compared to placebo at 5 minutes after the first dose and sustained through the 12 hour dosing interval6. Utibron Neohaler also showed clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared to placebo6. Health status was assessed using the St. George’s Respiratory Questionnaire (SGRQ)6 total score, which is a composite of symptoms, activities and impact on daily living.
Long-acting beta2-adrenergic agonists, such as indacaterol, one of the active ingredients in Utibron Neohaler, increase the risk of asthma-related death. Utibron Neohaler is not indicated for asthma and should not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms. The most common adverse reactions seen in the efficacy studies (incidence greater than or equal to 1% and higher than placebo) were sore throat, runny nose, high blood pressure and back pain6. Adverse reactions reported in the long-term safety trial were generally consistent with those observed in the 12week studies6.
Utibron and Seebri are delivered via the low resistance Neohaler inhaler, which makes it suitable for patients with different severities of airflow limitation.



1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2015. Available at Accessed August 11, 2015.

2. National Heart, Lung, and Blood Institute. Morbidity & Mortality: 2012 Chart Book on Cardiovascular, Lung, and Blood Diseases. Bethesda, Maryland: U.S Department of Health and Human Services, NIH, NHLBI. February 2012.

3. Centers for Disease Control and Prevention. Chronic Obstructive Pulmonary Disease. Page last updated: March 12, 2015. Accessed August 27, 2015.

4. Hoyert DL, Xu JQ. Deaths: preliminary data for 2011. Natl Vital Stat Rep. 2012;61(6):1-65. Hyattsville, MD: National Center for Health Statistics.2012.

5. Sin DD, Stafinski T, NG YC, Bell NR, Jacobs P. The impact of chronic obstructive pulmonary disease on work loss in the United States. Am J RespirCrit Care Med. 2002; 165: 704-707.

6. Utibron™ Neohaler® (indacaterol and glycopyrrolate) inhalation powder. East Hanover, NJ: Novartis Pharmaceuticals Corporation, October 2015.