March 6
Like hundreds of other executives whose companies are trying to develop blockbuster weight-loss drugs, Amylin Pharmaceuticals (AMLN) CEO Daniel M. Bradbury has been riveted by the saga of a once-promising medication called Acomplia. The Sanofi-Aventis (SNY) drug, which is on sale in 20 countries, got clobbered last June in a review by the U.S. Food & Drug Administration. Bradbury watched a live simulcast as an FDA advisory panel grilled Sanofi executives over the memory loss, dizziness, depression, and other side effects reported by people who took Acomplia in clinical trials. Most worrisome, at least four people on the drug committed suicide. When it came time to vote on whether the FDA should approve the drug, the results weren't pretty.
药品制造商
减肥药之战的内幕
就像其他数以百计的正在努力开发轰动性减肥药的公司执行官们一样,AMYLIN制药公司的首席执行官丹尼尔·M·布莱德贝里一直被笼罩在一度前途无量的Acomplia 疗法的传奇色彩之中。塞诺非-安万特公司的减肥药在20个国家销售。去年6月该药在美国食品和药品管理局的复审中被禁了。布莱德贝里看过美国食品和药品管理局的一个专家小组对塞诺非-安万特公司的执行官们就Acomplia疗法临床试验者所报告的记忆丧失、晕眩、压抑和其他副作用进行严厉责问的实况转播。最令人担心的是,至少有4个用药的人自杀了。当到了投票决定美国食品和药品管理局是否应该批准这种药上市时,结果不佳。