Poor Altana. The German drugs and chemicals group has withdrawn its European Marketing Authorisation Application (MAA) for its key COPD and asthma drug Daxas (roflumilast).
Roflumilast belongs to a class of drugs called phosphodiestrase-4 (PDE-4) inhibitors, which are thought to combat lung inflammation. No PDE-4 inhibitors, however, have yet been approved by the FDA and many experts are sceptical about the value of these drugs.
In April, Merck announced it was dropping development of a PDE-4 inhibitor because of safety concerns.
Altana said it had taken the decision after consulting with European regulators and that it would pursue the submission of a new MAA after further clinical data become available.
Insiders view: Dont hold your breath!
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