An advisory committee recommended today that the Food and Drug Administration (FDA) approve QAB149 (indacaterol) 75 mcg in the US as a once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
The committee voted 13 to four in favor of recommending approval of the 75 mcg dose. The advisory committee also voted 12 to five against recommending approval of the 150 mcg dose. The 75 mcg dose was seen as effective as the 150 mcg dose and the committee endorsed the safety of both doses.
The recommendation by the Pulmonary-Allergy Drug Advisory Committee (PADAC) followed a request from the FDA to further explore the efficacy and safety of lower doses of QAB149, an investigational medicine in the long-acting beta2-agonist (LABA) class.
The FDA has the option of seeking the advice of its advisory committees when it is reviewing a new drug for approval, although it is not obliged to follow the committee's recommendations.
"Novartis is committed to addressing the needs of patients with COPD and we are encouraged by the advisory committee's recommendation for approval of QAB149," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "The company is focused on bringing innovative, safe and effective treatment options to patients and physicians, and we will work closely with the FDA as it completes its review of QAB149."
The advisory committee reviewed an extensive program of clinical trials in which the efficacy of QAB149 at 75 and 150 mcg was studied in a total of 1,282 COPD patients in five key Phase III trials lasting 12-26 weeks. Results showed that both doses of QAB149 significantly improved lung function compared to placebo. These improvements were seen five minutes after the first dose and lasted for 24 hours.
The clinical trial program supporting US submission evaluated safety in 4,764 patients who received QAB149 for at least 12 weeks at doses of 75 mcg and greater, with results supporting the safety and tolerability profile of QAB149. The most commonly reported adverse events with both the 75 and 150 mcg doses were worsening of COPD, nasopharyngitis, cough, and headache.
"We must intensify our efforts to increase awareness, prevention and detection, and to develop new treatments to help reduce the enormous burden COPD places on patients, their families and our healthcare system," said John W. Walsh, president and co-founder of the US-based COPD Foundation. "Deaths from COPD are increasing much faster than previously projected, which should be a wake-up to all of us."
QAB149 is approved at 150 and 300 mcg once-daily doses in more than 50 countries worldwide under the brand-name Onbrez® Breezhaler®. Altogether, the clinical trial program for QAB149 involved more than 15,000 people of whom 9,243 were given QAB149 at varying doses and assessed for safety.
In the US, Novartis is seeking approval for the use of QAB149 as a once-daily long-term maintenance bronchodilator treatment for airflow obstruction in patients with COPD, including bronchitis and/or emphysema. Novartis is not seeking an indication for asthma. If approved in the US, the proposed brand name will be Arcapta™ Neohaler™.
COPD, a progressive and life-threatening lung disease making it difficult to breathe, affects more than 12 million people in the US, while another 12 million people are estimated to have the disease but are undiagnosed. COPD ranks as the third leading cause of death in the US and is a major cause of serious long-term disability.
Novartis Pharmaceuticals Corporation