Novartis’ COPD drug recommended for FDA approval
pharmafile | March 10, 2011 | News story | Sales and Marketing | Arcapta Neohaler, COPD, Novartis, Onbrez Breezhaler, QAB143, chronic obstructive pulmonary disease, indacterol
Novartis has won the backing of an FDA advisory committee for its chronic obstructive pulmonary disease (COPD) treatment QAB149.
The US regulator’s Pulmonary-Allergy Drug Advisory Committee voted 13 to four in favour of recommending the drug be approved after considering Novartis’ response to FDA requests for more efficacy and safety information.
The FDA is not obliged to follow the committee’s recommendations, but if it does Novartis will market the drug under the brand name Arcapta Neohaler.
QAB149 (indacterol), known as Onbrez Breezhaler in Europe where it is already approved, was submitted for US approval in 2008, but a 2009 Complete Response Letter from the FDA knocked it back with a request for more information on its dosing.
Trevor Mundel, global head of development at Novartis Pharma AG, 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.”
Novartis said it will work closely with the FDA, which has just given the green light to another COPD drug – Forest Laboratories’ Daliresp, in its ongoing review.
The FDA advisory committee reviewed five clinical trials comprising 1,282 COPD patients lasting 12-26 weeks, with results showing the treatment significantly improved lung function compared to placebo.
QAB149 is the first once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
COPD affects 210 million people worldwide and is projected to be the third leading cause of death by 2020. Associated with tobacco smoking, COPD is a life-threatening disease which causes obstruction of airflow in the lungs – resulting in debilitating bouts of breathlessness.
Brett Wells
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