FDA's Pulmonary-Allergy Drugs Advisory Committee voted to approve Novartis' QAB149 (indacaterol) 75 µg as a once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema, PR Newswire reported.
FDA’s Pulmonary-Allergy Drugs Advisory Committee voted to approve Novartis’ QAB149 (indacaterol) 75 µg 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, PR Newswire reported.
The committee voted 13 to 4 in favor of approval for the long-acting beta2-agonist (LABA) at a 75-µg dose, but voted 12 to 5 against approving the 150-µg dose. The 75-µg dose was demonstrated to be as effective as the 150-µg dose, and the committee endorsed the safety of both doses. Novartis is not seeking an indication for asthma.
If approved, the proposed brand name will be Arcapta Neohaler.
FDA rejected indacaterol in 2009, saying the proposed doses of 75 µg, 150 µg, and 300 µg were likely too high and not supported by the efficacy and safety data submitted by Novartis.
“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. Dr Mundel also said that Novartis will work closely with FDA as the agency completes its review of QAB149.
The advisory committee reviewed an extensive program of clinical trials in which the efficacy of QAB149 at 75 µg and 150 µg was studied in a total of 1,282 COPD patients in 5 key phase 3 trials lasting 12 to 26 weeks. Results showed that both doses of QAB149 significantly improved lung function compared to placebo. These improvements were seen 5 minutes after the first dose and lasted for 24 hours.
The clinical trial program supporting U.S. submission evaluated safety in 4,764 patients who received QAB149 for at least 12 weeks at doses of 75 µg and greater, with results supporting the safety and tolerability profile of QAB149. The most commonly reported adverse events with both the 75-µg and 150-µg doses were worsening of COPD, nasopharyngitis, cough, and headache.
QAB149 is approved at 150-µg and 300-µg 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.