The FDA has initiated a Iformal reviewJ of the investigationalnew drug application (IND) for fialuridine (FIAU), a chronichepatitis B drug licensed by Eli Lilly and Co. Phase II trials ofthe drug were suspended on June 26 after patients experiencedadverse events. Since then, two people have died followingliver transplants.
An FDA spokeswoman said no new testing of the drug will beallowed until the agency has thoroughly reviewed the IND anddata from the recently ended trial. Both Lilly and the NationalInstitutes of Health, which enrolled and treated the sickestpatients, are reviewing the data.
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