By Jennifer Corbett Dooren
WASHINGTON--A federal advisory panel voted to support the use of
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.
But many panel members said they struggled with their decisions
amid concerns about possible liver damage. The panel voted 9 to 6
in favor on a question that asked if Genzyme submitted enough
safety and effectiveness data to support marketing of
mipomersen.
Mipomersen, which has a proposed brand name of Kynamro, was
developed by Isis Pharmaceuticals Inc. (ISIS). The companies are
seeking approval of the product from the U.S. Food and Drug
Administration 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 isn't
the subject of the FDA's current review.
The drug was reviewed Thursday by the FDA's endocrinologic and
metabolic drugs advisory committee, which is made up of non-FDA
medical experts. The panel vote amounts to a recommendation that
the FDA approve the product.
Write to Jennifer Corbett Dooren at
jennifer.corbett@dowjones.com
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