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Celebrex to gain orphan drug indication

Published on 31/10/03 at 10:47am

Pfizer's blockbuster arthritis drug Celebrex is set to gain a European orphan drug licence for the treatment of a rare pre-cancerous condition, after receiving the backing of the Committee for Proprietary Medicinal Products.

The drug will be marketed as Onsenal for the treatment of familial adenomatous polyposis (FAP), a hereditary condition that predisposes patients to colon cancer. The drug will be used as an adjunct to surgery and further endoscopic surveillance.

The condition is characterised by the development of large numbers of potentially pre-cancerous polyps in the colon and rectum, many of which show high levels of the COX-II enzyme.

A COX-II inhibitor, Celebrex was granted orphan drug status for this indication in November 2001 and a decision on EU marketing authorisation is expected in the autumn.

The drug received FDA approval for the treatment of FAP in 1999, for which it continues to be marketed as Celebrex.

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