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FDA Reviewers Positive On Aegerion Pharmaceuticals Inc's Lipid Drug-Reuters


Monday, 15 Oct 2012 10:32am EDT 

Reuters reported that U.S. drug reviewers were positive on Aegerion Pharmaceuticals Inc's experimental drug for lipid disorder and said it showed a greater reduction in bad cholesterol as compared with statins, according to documents posted by the Food and Drug Administration on its website on October15, 2012. The FDA said an approval of the drug would require a risk evaluation and mitigation strategy to ensure that the benefits of lomitapide outweigh the risk of serious liver injury. The reviewers said additional safety data, collected through post-marketing studies, would be needed before deciding on whether the extent of hepatic steatosis, or excessive fat deposits in the liver, is sufficiently worrisome to discontinue the drug. The FDA review of Aegerion's lomitapide comes ahead of an advisory meeting of independent experts on Wednesday to discuss the drug. The FDA, which will consider the panel's recommendations, will take a final decision on the drug later. 

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