FDA Advisory Committee Recommends Approval of First Once-a-Day Long-acting Beta-agonist for COPD

March 09, 2011


Ifdy Perez, COPD Foundation
Tel: 1-866-731-2673, ext. 398

FDA Advisory Committee Recommends Approval of First Once-a-Day Long-acting Beta-agonist for COPD:
Foundation applauds decision, commends support for new therapies to improve lives of patient community

March 9, 2011, Washington, DC – A Food and Drug Administration (FDA) advisory committee has voted 13-4 that Indacaterol Maleate - a 75 mcg once-daily novel long-acting beta-adrenergic agonist (LABA) - is safe and effective at treating airflow obstruction in patients with COPD.

“We congratulate Novartis Pharmaceuticals for their commitment to developing new therapies and their recent recommendation for approval of the first once-a-day long-acting beta-agonist (LABA) for COPD,” says John W. Walsh, president and co-founder of the COPD Foundation.

“For a disease suspected of impacting over 20 million Americans, we have
struggled for far too long with a limited number of therapeutic
options,” says Dr. Byron Thomashow, Medical Director at New York Presbyterian Hospital and Chairman of the COPD Foundation. “The recommendation of approval of this new once-daily long-acting beta-agonist is a very positive step forward. It will give us another excellent option for improving the lives of those who live with this disease.”

According to the World Health Organization (WHO), non-adherence to treatment across chronic diseases is a worldwide problem of striking magnitude.

“Adherence to long-term therapy for chronic illnesses in developed countries
averages 50 percent. It is undeniable, many patients experience difficulty following treatment recommendations,” according to WHO. “Poor adherence to long-term therapies severely compromises treatment effectiveness making it a critical issue in population health from both quality of life and health economic perspectives.”

According to MedPageToday, indacaterol was rejected by the FDA in 2009 because “the proposed doses of 75 mcg, 150 mcg, and 300 mcg were likely too high and not supported by the efficacy and safety data submitted.” Novartis Pharmaceuticals subsequently provided the FDA with new data studying lower doses that showed lung function was improved after 12 weeks of treatment.

The availability of a new option, a once-a-day drug, can positively impact patient adherence to their treatment regimen, which will improve their quality of life.

“This is a significant step forward to improving the lives of individuals with COPD. Before today, the only available drugs for COPD were twice-a-day or nebulized, as according to treatment guidelines,” says Walsh.

About the COPD Foundation

The COPD Foundation is dedicated to developing and supporting programs which improve the quality of life through research, education, early diagnosis, and enhanced therapy for persons whose lives are impacted by Chronic Obstructive Pulmonary Disease (COPD). The COPD Foundation has several programs dedicated to informing, empowering, educating, and engaging individuals affected by COPD, including both diagnosed and undiagnosed individuals, their families and friends, and their medical professionals. For more information, please visit: http://www.copdfoundation.org.

About COPD

Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death in the U.S. and the only chronic disease growing in mortality. It affects approximately 24 million Americans but only 12 million are diagnosed. COPD includes chronic bronchitis, emphysema, and adult onset (refractory) asthma. Symptoms include breathlessness, wheezing, and chronic coughing. For more information about COPD, visit http://www.copdfoundation.org or call 1-866-316-COPD (2673)