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interdetect 发表于 2011-4-6 09:02 
当年美国FDA批准了BMS的恩替卡韦上市，但要求其上市后开展以下10项研究及其他FDA认为需要进行的必要研究。
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再问: 自2005年以来,美国FDA有没有发出任何警告?
11 March 2005
FDA Antiviral Drug Advisory Committee Recommends Unanymously to Approve Entecavir for Hepatitis B
Today March 11, the FDA Antiviral Drug Advisory Committee met in Gaithersburg, Maryland to hold a public hearing to consider the approval of entecavir for treatment for hepatitis B chronic infection. The brand name for entecavir is Baraclude.
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Under discussion today was the finding of tumors in rodents in pre-clinical studies of entecavir. The FDA cancer advisory group met & discussed this before today, and felt this finding was relevant to humans. This was the subject of much discussion at the hearing. The committee & the FDA felt that we cannot extrapolate the findings in rodents to humans. There may be a risk for humans but we cannot tell based on studies in rodents. They talked about how similar cancerous toxicities were observed preclinically with certain HIV antiretrovirals. The FDA & the committee considered the risk/benefit ratio, weighing the worldwide problem of hepatitis B & the seriousness of this disease, the need for more therapies, and the finding of tumors in rodents. Every committee member and the FDA felt that the benefit of approving entecavir outweighed potential risks. HBV can lead to liver cancer, cirrhosis, and death. All three drugs currently approved for HBV treatment have limitations. Interferon is difficult to tolerate. Adefovir has potential nephrotoxicity. And lamivudine is associated with significant drug resistance. The FDA & the committee found that entecavir should be approved for firstline and secondline HBV therapy. Due to the finding of tumors in rodents taking entecavir and the potential for humans to develop malignancies, Bristol Myers Squibb proposed a post approval safety study that would evaluate the risk for cancers developing in patients 5 to 8 years after starting entecavir, So far in the clinical studies there does not appear to be malignancies associated with entecavir. The FDA and the committee expressed satisfaction with a proposed Safety Study. The details of the study design was the subject of much discussion today, however.
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发表于 2011-4-6 09:02
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