Draft guidance from UK's NICE recommends clinical trial for COPD drug Daxas

New draft guidance from the UK's drug watchdog the National Institute for Health and Clinical Excellence (NICE) recommends the use of Daxas (roflumilast), in the context of research, as part of a clinical trial for adults with severe chronic obstructive pulmonary disease, associated with chronic bronchitis, as an add on to bronchodilator treatment for people with a history of frequent exacerbations.

The drug was developed by Switzerland's Nycomed and is licensed to US pharma giant Merck & Co (NYSE: MRK) for the European market. It received European Commission approval last year (The Pharma Letter July 7, 2010).

After carefully considering the evidence, the NICE’s independent appraisal committee concluded there was great uncertainty about the effect of roflumilast on reducing the rate of exacerbations as an add-on to triple or dual therapy for people with severe COPD. For that reason, the draft guidance recommends setting up a trial to assess its clinical effectiveness for this indication. The draft guidance also recommends that it should be compared with theophylline in people for whom this drug might be suitable.