Login to Your Account

Final Labeling with FDA

Despite EU Denial, Isis Bullish On FDA Approval for Kynamro

By Brian Orelli
BioWorld Insight Contributing Writer

Tuesday, January 22, 2013

Last month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion of the marketing authorization application for Kynamro (mipomersen), developed by Isis Pharmaceuticals Inc. and Genzyme Corp., a unit of Sanofi SA, for the treatment of homozygous familial hypercholesterolemia (HoFH). Genzyme is appealing the decision, which should be completed in the second quarter of 2013.

To continue reading subscribe now to BioWorld Insight

Learn More about BioWorld Insight

Already a subscriber? Sign In or Buy now to activate your subscription