Tuesday, November 15, 2005

Altana - Daxas hopes dashed

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 The German drugs and chemicals group has withdrawn its European Marketing Authorisation Application (MAA) for its key COPD and asthma drug Daxas (roflumilast).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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