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Kynamro gets thumbs down from CHMP

December 15, 2012 2:04 AM UTC

EMA's CHMP issued a number of negative opinions on Friday, including a recommendation against approval of an MAA for Kynamro mipomersen from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) to treat homozygous familial hypercholesterolemia (hoFH). The committee said that while Kynamro was effective at reducing LDL-C, the product's cardiovascular benefit does not outweigh its cardiovascular risk. CHMP also said it was concerned about liver toxicity and the rate of discontinuations for the product. Genzyme, which said it plans to request a reexamination, has exclusive rights to the compound from Isis Pharmaceuticals Inc. (NASDAQ:ISIS), which was up $0.37 to $9.98 on Friday.

In October, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 9-6 in favor of approving Kynamro for hoFH, but expressed concerns about the product's "modest efficacy," high discontinuation rates and hepatotoxicity. The second-generation antisense inhibitor of apolipoprotein B-100 (APOB-100) mRNA has a Jan. 29 PDUFA date (see BioCentury, Oct. 29). ...