Onsenal celecoxib regulatory update

EMA's CHMP recommended against off-label use of Pfizer's Onsenal celecoxib to reduce the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP). CHMP said the benefits of the cyclooxygenase-2 (COX-2) inhibitor did not outweigh the increased risk of cardiovascular and gastrointestinal side effects. EMA said CHMP conducted the review due to concerns that Onsenal may be used off-label following the European Commission's withdrawal of marketing authorization of the product in FAP earlier this year. The move followed Pfizer's decision to voluntarily withdraw the product for the indication after it was unable to provide the agency with further safety and efficacy data, which was requested as part of the EC's approval under exceptional circumstances in 2003, due to slow enrollment in an ongoing clinical trial (see BioCentury, April 11). ...