Setback for AstraZeneca Drug
Updated from 10:04 a.m. EDT
A staff report by the Food and Drug Administration raised significant concerns Thursday about liver damage stemming from long-term use of an experimental drug made by AstraZeneca (AZN).
The staff report, issued a day before an FDA advisory committee meets to discuss the experimental blood thinner Exanta, could be a serious blow for the U.K.-based drug company.
The FDA staff report's documents on safety and efficacy on Exanta "look downright bad," said Dr. Tim Anderson, a drug industry analyst for Prudential Equity Group, in a research report to clients Thursday. "Prior to seeing the documents, we had forecasted odds of approval at 60/40.
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