Despite EU Denial, Isis Bullish On FDA Approval for Kynamro
BioWorld Insight Contributing Writer
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.
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