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Isis Pharmaceuticals Inc.
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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