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FDA Reviewers Say Sanofi SA And Isis Pharmaceuticals Inc Lipid Drug Effective, But Flag Risks-Reuters


Tuesday, 16 Oct 2012 09:23am EDT 

Reuters reported that U.S. drug reviewers said Sanofi SA and Isis Pharmaceuticals Inc's lipid disorder drug Kynamro showed highly significant efficacy, but added that the high dropout rate in patients taking the drug could be a problem, according to documents posted on the regulator's website. U.S. Food and Drug Administration reviewers said the drug was highly effective in reducing "bad" cholesterol over 26 weeks according to the reviewers’ analyses and data submitted by the companies. But they also said that a high discontinuation rate due to adverse events could pose problems for a therapy that needs to be taken chronically. The reviewers said there was no data to show the efficacy of the drug for possible long-term treatment, and that a risk mitigation strategy was needed to ensure the benefits of drug outweighed the potential risk of serious liver injury. The drug is intended to reduce so-called bad cholesterol in patients with a lipid disorder who are already on a stable regimen of lipid-lowering therapies, and who require additional lipid-lowering therapy. The disorder, called familial hypercholesterolemia, is a genetic disease that results in elevated bad cholesterol levels and increased risk of premature heart disease. The FDA, which will take into account the independent panel's recommendations, is expected to make a final decision on the drug by January 29, 2013. 

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