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news.Novartis said that the Pulmonary-Allergy Drug Advisory Committee (PADAC) has recommended the US Food and Drug Administration for the approval of QAB149 (indacaterol) in the US as an once-daily maintenance bronchodilator to treat airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
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QAB149 is approved at 150 and 300mcg once-daily doses in more than 50 countries worldwide under the brand-name Onbrez Breezhaler.
The recommendation 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 advisory committee has reviewed data from clinical trials evaluated QAB149 at 75 and 150mcg doses which demonstrated that in both the doses QAB149 improved lung function compared to placebo.
Novartis Pharma Development global head Trevor Mundel said Novartis is committed to addressing the needs of patients with COPD and they are encouraged by the advisory committee’s recommendation for approval of QAB149.
"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," Mundel said.