Sosei Group Corporation confirms that the 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.
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).
In the efficacy studies, Utibron Neohaler demonstrated superior and sustained improvements in lung function (FEV 1 AUC 0-12 ) 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-daily 6. 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 6. 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 beta 2 -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 pain 6. Adverse reactions reported in the long-term safety trial were generally consistent with those observed in the 12-week studies.
Utibron and Seebri are delivered via the low resistance Neohaler inhaler, which makes it suitable for patients with different severities of airflow limitation.