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Dec 17, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Kynamro mipomersen regulatory update

EMA's CHMP issued a negative opinion recommending against approval of an MAA for Kynamro mipomersen from Sanofi's Genzyme Corp. unit to treat homozygous familial hypercholesterolemia (hoFH). CHMP said that while Kynamro was effective at reducing LDL-C, it was concerned about the compound's safety. The committee noted that a greater proportion of patients receiving Kynamro had...

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