EU clears Nycomed's Daxas for patients with COPD; German and UK launches soon
Independent Swiss drugmaker Nycomed says that the European Commission has granted marketing authorization for Daxas (roflumilast) in the European Union. Daxas is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of chronic obstructive pulmonary disease (COPD), a progressive, life-threatening lung disease.
The decision was widely expected after a European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) gave its backing to the drug (The Pharma Letter April 23), but Daxas' approval is still delayed in the USA, where the Food and Drug Administration has requested certain additional data and analysis, though no new clinical trials (TPL May 18)
Nycomed has a marketing deal with Merck & Co for Europe and Canada, while Forest Laboratories holds US rights to the drug (TPLs passim).
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