FDA orphan approval
January 31, 2013
THE US Food and Drug
Administration ahs approved
Kynampro (mipomersen sodium)
injection as an addition to lipidlowering
medications and diet to
treat patients with a rare type of
high cholesterol called homozygous
familial hypercholesterolemia.
Also known as HoFH, it’s an
inherited condition which affects
about one in a million people
across the USA.
It occurs when the body is unable
to remove LDL-C from the blood,
causing abnormally high levels of
circulating LDL-C.
Last month the FDA also
approved Juxtapid (lomitapide) to
reduce LDL-C, total cholesterol,
apoliprotein B, and non-HDL-C in
patients with HoFH.
Kynampro is administered once
per week, with the FDA also
requiring four postmarketing
studies for the drug.
The FDA is also mandating a longterm
registry of patients with the
condition to determine the longterm
safety of the drug, and an
enhanced pharmacovigilance
program.
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