WEDNESDAY, Jan. 30 (HealthDay News) -- Kynamro (mipomersen
sodium) has been approved by the U.S. Food and Drug Administration
to treat a rare inherited condition in which the body can't remove
low-density lipoprotein (LDL) cholesterol from the blood.
LDL is the so-called "bad" cholesterol that can clog the
arteries and cause heart attack and stroke. Many people with
homozygous familial hypercholesterolemia (HoFH) have a heart attack
and die before age 30, the FDA said in a news release.
HoFH affects approximately one of every 1 million people in the
United States. Kynamro is a once-weekly injection designed to lower
creation of blood lipid particles that ultimately form LDL, the
agency said.
The drug was clinically evaluated among 51 people with HoFH.
Among Kynamro users, LDL levels fell an average of about 25 percent
during the first 26 weeks, the FDA said. The drug will carry a
"black box" label warning of possible liver abnormalities that
could lead to progressive liver disease.
More common side effects noted during clinical testing included
injection-site reactions, flu-like symptoms, nausea, headache and
elevated liver enzymes.
Kynamro is produced by Genzyme Corp., of Cambridge, Mass.
More information
To learn more about
high
cholesterol, visit the U.S. National Library of Medicine.