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news.Pfizer has agreed not to launch its COX-2 Onsenal in the European Union, following part of an ongoing review of the COX-2 class by European regulators.
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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 Onsenal, Dynastat and Bextra, Merck Sharp & Dohme for Arcoxia and Novartis for Prexige on 18 January, 2005.
Further to its assessment of data submitted on Onesal (celecoxib), the Committee requested further clarifications and analyses, in particular of data from the APC and PreSAP studies.
Onsenal is used in the orphan 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 Merck’s Vioxx (rofecoxib). Following discussions with the Committee, Pfizer has agreed not to launch Onsenal in the EU pending finalization of the assessment.
Data on other COX-2 inhibitors are currently being assessed. The CHMP will continue its discussions on the review at its next meeting on February 14 to 17, 2005.