ALTANA: Top line results of first one-year COPD study with Daxas
Following the announcement of the termination of the Daxas® (roflumilast) collaboration with Pfizer, ALTANA disclosed the top line results of the first one-year COPD study of Daxas®. The phosphodiesterase4 (PDE4)-inhibitor Daxas® is an oral investigational, steroid free anti-inflammatory agent being studied for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.
In the COPD study "RATIO/M2-112" the primary endpoint of lung function (FEV1) significantly improved with roflumilast treatment compared to placebo.The frequency of moderate and severe exacerbations was a co-primary endpoint. There was no statistically significant reduction in the rate of total exacerbations (7% reduction). The most common adverse events associated with roflumilast treatment were nausea, headache and diarrhea.
After the termination of the Daxas® collaboration with Pfizer ALTANA will continue the development of Daxas®. A marketing authorization application (MAA) for Daxas® is under evaluation by regulatory agencies in Europe.
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