Novartis today has announced that the Phase 3 FLAME study demonstrated that the Utibron Neohaler (Ultibro Breezhaler) indacaterol/glycopyrronium DPI reduced the rate of COPD exacerbations more effectively than the Advair (Seretide) fluticasone/salmeterol DPI over a 52-week period. FLAME involved over 3,360 COPD patients in 43 countries and was designed to demonstrate the non-inferiority of Utibron Neohaler/Ultibro Breezhaler to fluticasone/salmeterol.
Ultibro Breezhaler was approved in Europe in September 2013, and the FDA approved Utibron Neohaler in October 2015.
Novartis Global Head of Development Vasant Narasimhan commented, “Today’s FLAME study results provide clear further evidence that Ultibro Breezhaler is more effective than Seretide in reducing COPD exacerbations, events linked to significant patient suffering and more rapid progression of the disease. We believe FLAME challenges our historical reliance on inhaled corticosteroids and may support expanding the use of dual bronchodilators to both exacerbating and non-exacerbating COPD patients.”
Read the Novartis press release.
