Pfizer has withdrawn Onsenal (celecoxib) after concluding that it is unable to meet the conditions of the product’s marketing authorisation.
Onsenal was launched in June 2010 as an adjunct to surgery and further endoscopic surveillance in the treatment of familial adenomatous polyposis. Approval for this rare condition was granted on the basis of data showing a reduction in polyp number following treatment with the COX-2 inhibitor. At the time of approval the EMA requested that the manufacturer provide post-approval data on clinically relevant efficacy outcomes. The long-term placebo-controlled Children’s International Polyposis trial was initiated in response to this request, but the trial has progressed too slowly to meet its enrolment goals. Celecoxib remains available as Celebrex for osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Further Information: Pfizer