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FDA Reviewers Focus on Liver Risks of Genzyme HoFH Drug, Analyst Expects Approval
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Thursday will discuss a number of liver-related and carcinogenic adverse events seen in four Phase III trials of Genzyme and Isis Pharmaceuticals’ Kynamro as a treatment for homozygous familial hypercholesterolemia (HoFH), a life-threatening genetic disorder.
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