The Pulmonary-Allergy Drugs Advisory Committee (PADAC) of the US FDA has voted to recommend approval of the 75 mcg dose of Novartis’s QAB149 indacaterol dry powder formulation for the treatment of COPD but has voted against approval of the 150 mcg dose. The vote was 13 to 4 in favor of the lower dose and 12 to 5 against recommendation of the higher dose.
Trevor Mundel, Global Head of Development at Novartis said, “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.” The company says that it has no plans to seek approval of the product for the treatment of asthma.
Novartis already markets the product in 150 mcg and 300 mcg doses under the name Onbrez Breezhaler in more than 50 countries. If approved in the US, the product will be called Arcapta Neohaler.
Read the company’s press release.
