Update from the European Medicines Agency on COX-2 inhibitors

20 January 2005

As part of the ongoing review of COX-2 inhibitors, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) held hearings with Pfizer (for celecoxib, parecoxib and valdecoxib), Merck Sharp & Dohme (for etoricoxib) and Novartis (for lumiracoxib) on 18 January 2005.

Further to its assessment of data submitted on celecoxib, the Committee requested further clarifications and analyses, in particular of data from the Adenoma Prevention with Celecoxib (APC) and Prevention of Spontaneous Adenoma Polyps (PreSAP) studies.

The review includes Onsenal (celecoxib), which is used in the orphan (rare) indication in the treatment of adenomatous intestinal polyps in familial adenomatous polyposis. This is a similar treatment area as looked at in the APC and PreSAP celecoxib studies and also the APPROVe study that led to the withdrawal of Vioxx (rofecoxib). Following discussions with the Committee, Pfizer has agreed not to launch Onsenal in the European Union pending finalisation of the assessment.

Data on other COX-2 inhibitors (etoricoxib, lumiracoxib, parecoxib and valdecoxib) are currently being assessed. The CHMP will continue its discussions on the review at its next meeting on 14-17 February 2005.

Update from the European Medicines Agency on COX-2 inhibitors

Reference Number: EMEA/23547/2005