Aegerion stumbles on standard review disappointment
This article was originally published in Scrip
Executive Summary
Barely a day after Aegerion Pharmaceuticals revealed it had submitted US and European applications for lomitapide as a therapy to reduce cholesterol in patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic lipid disorder, the company disclosed that the US FDA would not grant a six-month priority review – news investors did not swallow well (scripintelligence, 6 March 2012).