FDA Questions Safety Of Genzyme's Kynamro

Law360, New York (October 16, 2012, 7:56 PM EDT) -- Genzyme Corp.’s bid for approval of cholesterol disorder treatment Kynamro is facing a potential setback, after a U.S. Food and Drug Administration research report released Tuesday flagged a number of concerns over serious side effects of the drug.

According to the briefing, written by FDA researchers, while several Phase III clinical trials for Kynamro had shown it was effective at lowering low density lipoprotein, or “bad” cholesterol, in trial participants, the trials had also resulted in high participant dropout rates due to side effects of the...
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