FDA Panel Recommends Approval Of Genzyme's Kynamro

Law360, Washington (October 19, 2012, 7:48 PM EDT) -- A U.S. Food and Drug Administration advisory committee on Thursday recommended the agency approve Genzyme Corp.'s and Isis Pharmaceuticals Inc.'s cholesterol disorder treatment Kynamro, despite previous staff concerns about serious side effects.

In a narrow 9-6 vote, FDA's Endocrinologic and Metabolic Drugs Advisory Committee determined the companies had provided enough safety and efficacy data for the homozygous familial hypercholesterolemia drug to warrant agency approval. In particular, the committee recommended FDA approve the drug for patients with the rare genetic disease who have extremely high levels of...
To view the full article, register now.