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Nycomed Announces FDA Filing for Daxas(R) in COPD
Date:7/20/2009

ZURICH, July 20 /PRNewswire/ -- Nycomed today announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Daxas(R) 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(R) (roflumilast) in the treatment of symptomatic COPD. Two pivotal 12-month studies showed positive effects on exacerbation rates and pulmonary function (FEV(1)). 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.


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