Roflumilast: a novel approach to the management of COPD

Nycomed have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for roflumilast (Daxas) as a once-daily oral treatment for patients with COPD associated with chronic bronchitis.

Roflumilast is the first of a new class of drugs for treatment of COPD, anticipated to act upon the underlying mechanism of COPD. It is an orally-administered phosphodiesterase 4 (PDE4) enzyme inhibitor that targets cells and mediators in the body believed to be important in the COPD disease process, and may help to reduce exacerbations (episodes of worsening).

Two pivotal 12-month phase III studies of roflumilast in symptomatic COPD met their primary endpoints, showing beneficial effects on exacerbation rates and pulmonary function (FEV1). Two additional 6-month studies also confirmed the efficacy of roflumilast when used with standard bronchodilator treatments. Full data from all four studies are to be published during 2009.

COPD is a serious and irreversible lung disease resulting in difficulty in breathing, and 80 million people have moderate to severe COPD worldwide. Recent figures from the British Thoracic Society show that more than 27 000 people die of COPD each year in the UK.