Nycomed should hear in the coming weeks what European regulators make of its COPD drug, Daxas, the first of a chain of opinions due over the next couple of months which will help define the potential, clinically and commercially, of this novel approach to treating the debilitating lung disorder.

Daxas, or roflumilast, has overcome much scepticism to get this far; as well as belonging to a class with no notable successes the PDE4 inhibitor itself struggled to establish efficacy in the first round of pivotal trials conducted ten years ago. However, more recent studies have begun to shift opinions. With an FDA advisory committee hearing likely in March or April in the US, ahead of a May 20 PDUFA date, many will be looking to this first regulatory appraisal to help shed light on the passage to market for Daxas; the owner of US marketing rights, Forest Laboratories, in particular.