Novartis reported on two Phase III studies demonstrating that treating COPD using its marketed once-daily OnBrez® Breezhaler® (indacaterol) in addition to tiotropium (Boehringer Ingelheim’s long-acting anti-muscarinic [LAMA] drug Spiriva® HandiHaler®) improves lung function to a significantly greater degree than tiotropium therapy alone. The Intrust 1 and Intrust 2 studies were matching 12-week placebo-controlled studies involving a total of 2,276 patients with moderate-to-severe COPD. The primary endpoint was improvements in lung function measured by FEV1.
Novartis claims Onbrez Breezhaler is the only marketed once-daily, long-acting beta-2 agonsit (LABA). “Previous studies have confirmed the efficacy of Onbrez Breezhaler as monotherapy, and these data show the potential for additional lung function benefits when two of the leading classes of treatment for COPD are combined,” remarks Trever Mundel, M.D., global head of development at Novartis Pharma. “These data support the treatment approach of combining bronchodilators of different classes as recommended in the internationally recognized GOLD guidelines for managing COPD.”
Onbrez Breezhaler was first approved in November 2009 in the EU, for the maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD. The drug is currently approved in over 50 countries, and has been launched in 13 territories within Europe. FDA regulatory review of the marketing application in the U.S. is scheduled for March 2011. If approved, the treatment will be trademarked Arcapta® Neohaler.