July 20, 2009
NDA submitted for Daxas for chronic obstructive pulmonary disease (COPD)Nycomed announced the submission of a New Drug Application (NDA) to the FDA for Daxas (roflumilast) as a once-daily oral treatment for symptomatic chronic obstructive pulmonary disease (COPD). The NDA submission is based on results from four Phase 3 trials of Daxas in the treatment of symptomatic COPD. Two pivotal 12-month studies showed positive effects on exacerbation rates and pulmonary function (FEV). Two supporting six-month studies also confirmed the efficacy of Daxas when used with standard bronchodilator treatments.
Daxas is an orally administered phosphodiesterase 4 (PDE4) enzyme inhibitor targeting cells and mediators believed to be important in the COPD disease process. Daxas is expected to act on the underlying mechanism of COPD and related inflammatory diseases.
For more information visit www.nycomed.com.