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.
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