FDAnews has teamed Chris Sloan, Quintiles Consulting, and Michael Morton, Medtronic, in a 90-minute presentation on the FDA advisory panel process. You’ll discover tips and guidance that are the fruit of a combined five decades of device regulatory experience.
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. Drug Industry Daily