Positive EMA opinion for Nycomed’s Daxas. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for the Nycomed GmbH medicine, Daxas (roflumilast) for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD). The opinion was issued on 23 April, 2010. Roflumilast is an anti-inflammatory agent designed to target both the systemic and pulmonary inflammation associated with COPD. It does this by reducing the activity of phosphodiesterase 4 (PDE4), an enzyme found in body cells which is important to the pathogenesis of COPD. The review of the application started in 27 May 2009 and was under active assessment for 210 days. The benefits of the drug are its ability to reduce inflammation in the lungs, to reduce narrowing of airways and to ease breathing problems in adults with severe COPD, the agency said.
