Bristol Myers-Squibb and Pfizer ended a phase III clinical trial of anticoagulant apixaban in patients with acute coronary syndrome. In an announcement, BMS said it remains committed to developing apixaban in other populations and hinted that a rolling NDA for approval of apixiban for stroke in atrial fibrillation is under way. Apixaban is also in phase III trials for VTE prevention.
FDA's Oncologic Drugs Advisory Committee postponed a Dec. 2 meeting to review BMS cancer drug ipilimumab, trade name Yervoy. According to a source at FDA, a new ad-com date has not been set. BMS submitted a BLA for the treatment of adults with advanced melanoma to the FDA in August, and the original PDUFA date was set for December 25, 2010.
Xanodyne Pharmaceuticals said it is voluntarily pulling its Darvon, Darvon-N and Darvocet-N painkillers from the US market as part of a market-wide withdrawal of all propoxyphene-containing products. FDA determined that the benefits of these products no longer outweigh potential risks, noted Xanodyne in a statement which specifically mentioned propoxyphene's effects on cardiac conduction. A number of other branded and generic versions of the 50-year-old drug are affected, it said.
An FDA advisory panel voted 13-2 to recommend approval of lupus drug Benlysta, which is being developed by Human Genome Sciences and GlaxoSmithKline. The FDA is set to make a final decision on the drug Dec. 9. The agency doesn't have to follow the advice of its advisory panels but generally does.