US FDA accepts Kynamro NDA, but Genzyme/Isis snubbed on priority review
This article was originally published in Scrip
Executive Summary
While the US FDA accepted Genzyme's new drug application (NDA) for Kynamro (mipomersen sodium), the firm failed to snag a six-month priority review for the drug as a treatment for patients with homozygous familial hypercholesterolemia (HoFH), a rare, genetic cardiovascular disease.