Roflumilast, new COPD drug

Published: 2010-08-04

The European Commission has approved Nycomed's Daxas (roflumilast) as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD), the company reported on 6 July 2010. The once-daily oral drug, which will be promoted in selected European countries, is expected to be launched shortly, starting first with Germany and the UK.

Daxas is indicated in Europe for the maintenance treatment of severe COPD associated with chronic bronchitis in adults with a history of frequent exacerbations as an add-on to bronchodilator treatment. Nycomed notes that the decision was based on positive results from four late-stage studies involving more than 3,000 patients with COPD, in which the drug demonstrated a significant improvement in moderate to severe exacerbations, as well as a measure of lung function.

Roflumilast is the first new class of treatment for COPD in more than a decade.

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