FDA: Genzyme Corporation (GENZ), Isis Pharmaceuticals, Inc. (ISIS) Drug Mipomersen Cuts Cholesterol but Impacts Liver
10/16/2012 7:54:23 AM
Food and Drug Administration medical reviewers said mipomersen, a drug that would be marketed by Sanofi's (SNY, SNY.FR) Genzyme unit to treat a rare form of a disease that causes very high cholesterol was effective at reducing cholesterol, but raised concerns about the safety of the product.
Mipomersen, which has a proposed brand name of Kynamro, was developed by Isis Pharmaceuticals Inc. (ISIS). The companies are seeking FDA approval of the product to treat people with a condition called homozygous familial hypercholesterolemia, or HoFH, a disorder that causes very high cholesterol. The FDA estimates it affects one person out of one million people in the U.S. The companies are also developing the product for use in a different type of familial hypercholesterolemia, which affects more people, but that use is not the subject of FDA's current review.