Isis Pharma Issues Update on CHMP Opinion on KYNAMRO
Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that following Genzyme's request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its previous position and has maintained a negative opinion regarding the marketing authorization application (MAA) for KYNAMRO^TM (mipomersen) as a treatment for patients with Homozygous Familial Hypercholesterolaemia (HoFH).
The FDA approved KYNAMRO in the United States in January 2013 for the treatment of patients with Homozygous Familial Hypercholesterolaemia.
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