Nycomed Announces FDA Filing For Daxas(R) In COPD
Nycomed announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Daxas® as a once-daily oral treatment for patients with symptomatic COPD. The NDA submission is based on encouraging results from four Phase III trials of Daxas® (roflumilast) in the treatment of symptomatic COPD. Two pivotal 12-month studies showed positive effects on exacerbation rates and pulmonary function (FEV1). Two supporting six-month studies also confirmed the efficacy of Daxas when used with standard bronchodilator treatments. Full data from all four studies are to be published during 2009.
Cardiovascular