Novartis has received a Complete Response letter from the US Food and Drug Administration (FDA) as part of the US regulatory review for QAB149 (indacaterol), an investigational once-daily bronchodilator for the treatment of adult patients with chronic obstructive pulmonary disease (COPD).
The FDA has requested additional information on the dosing proposed for QAB149. Novartis will work with the FDA to review already submitted data for QAB149 as well as recently available data to determine what, if any, further clinical trials would be required.
"We will continue to work closely with the FDA to gain US regulatory approval for QAB149, which we believe could offer an important new treatment option for patients with COPD," said Trevor Mundel, global head of Development at Novartis Pharma AG. "Our confidence in the benefit/risk profile of QAB149 is based on results of phase-III trials which showed QAB149 significantly improved lung function in patients with this severe disease and provided clinically relevant improvement in symptoms such as breathlessness compared to other bronchodilators."
QAB149 was submitted for US regulatory approval in December 2008 as a new once-daily bronchodilator for maintenance treatment of airflow obstruction in patients with COPD. The original submission was based on a phase-III clinical trial programme with three pivotal studies and enrolled 4,400 patients with moderate-to-severe COPD.
In Europe, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in September 2009 supporting regulatory approval of QAB149 as a once-daily therapy with two doses (150 micrograms and 300 micrograms). The European Commission generally follows the recommendations of the CHMP, which is the scientific committee of the European Medicines Agency.