The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has finalised that existing evidence of safety and efficacy does not support the use of celecoxib in the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP).
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.
Celecoxib-containing products are currently authorised in the European Union for the treatment of the symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. This review was initiated because of concerns that celecoxib may be used off-label in the FAP indication following the withdrawal of Onsenal.
The CHMP concluded that the benefit of celecoxib in FAP patients had not been sufficiently demonstrated and did not outweigh the increased risk of cardiovascular and gastrointestinal side effects, which would result from high dose and long-term treatment used in FAP patients.
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