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24 May 2011

CHMP Ends Review on Use of COX-2 Inhibitor Celecoxib

The European Medicines Agency concludes on use of celecoxib in familial adenomatous polyposis.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has finalised its review of the use of the COX-2 inhibitor celecoxib in the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP). The CHMP concluded that existing evidence of safety and efficacy does not support the use of celecoxib in FAP patients.


This review follows Pfizer’s voluntary withdrawal of the marketing authorisation of its celecoxib-containing orphan medicine, Onsenal, which had been authorised for use in FAP patients. The reason for the withdrawal was that Pfizer was unable to provide confirmatory data regarding clinical benefit due to slow enrolment in a clinical trial. These data had been requested by the CHMP at the time of granting of the marketing authorisation for Onsenal.

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