FDAnews Drug Daily Bulletin

FDA Advisory Panel Narrowly Recommends Genzyme HoFH Drug

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The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 9–6 Thursday to recommend approval of Genzyme and Isis Pharmaceuticals’ homozygous familial hypercholesterolemia (HoFH) drug Kynamro. The vote comes one day after the panel recommended approval of Aegerion’s HoFH treatment by a wider margin. As with Aegerion’s lomitapide, EMDAC panelists expressed numerous concerns over Kynamro’s (mipomersen) safety profile.
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