Chronic Obstructive Pulmonary Disease
Nycomed Announces FDA Filing for Daxas(R) in COPD
Published in Medical Letter on the CDC and FDA, August 9th, 2009
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 (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.
In May 2009, Nycomed also completed the submission of a...
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