Altana has withdrawn the European Marketing Authorisation Application (MAA) for Daxas (roflumilast). Altana Pharma has taken this decision after consulting with the EMEA. The submission of a new MAA will be pursued, after further clinical data are available.
According to the company release, Altana Pharma will continue the development of Daxas and will pursue further clinical studies to strengthen the anti-inflammatory product profile and possible market potential of Daxas.
The phosphodiesterase4 (PDE4)-inhibitor Daxas (roflumilast) is an oral investigational, steroid free anti-inflammatory agent being studied for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.