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Aegerion, Genzyme HoFH products clear FDA panel; how doctors will use is unclear
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Monday, October 29, 2012
If FDA follows its advisory panel's recommendation, Aegerion
Pharmaceuticals Inc. and Sanofi's
Corp. unit could each be launching new drugs to treat the ultra-Orphan
disease homozygous familial hypercholesterolemia early next year. But neither
the panel discussion nor the companies' clinical trials give doctors much of an
idea of how and when to use one drug over the other.
The 15 members of the
Endocrinologic and Metabolic Drugs Advisory Committee included only one doctor
who treats hoFH patients. The remaining members included hepatologists brought
in to discuss elevations in hepatic enzymes and hepatic fat seen with both
compounds, as well as statisticians, epidemiologists, endocrinologists,
cardiologists and a gastroenterologist.
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