Genzyme, a Sanofi company (SNY), and Isis Pharmaceuticals Inc. (ISIS), announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for KYNAMROTM for the treatment of patients with Homozygous Familial Hypercholesterolaemia. Genzyme plans to request a re-examination of the CHMP Opinion.
An application for KYNAMRO is currently under review by the U.S. FDA.
by RTT Staff Writer
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