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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Silver Spring, MD 20993
TRANSMITTED BY FACSIMILE
Marc Beer
Chief Executive Officer
Aegerion Pharmaceuticals, Inc.
101 Main Street, Suite 1850
Cambridge, MA 02142
RE: NDA 203858
JUXTAPID
™
(lomitapide) capsules, for oral use
MA #31
WARNING LETTER
Dear Mr. Beer:
This letter notifies Aegerion Pharmaceuticals, Inc. (Aegerion) that the Office of Prescription
Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has become aware
of statements that you made regarding JUXTAPID
™
(lomitapide) capsules, for oral use
(Juxtapid) during broadcast interviews on CNBC’s television show, “Fast Money,” that aired
on June 5, 2013, and October 31, 2013. The statements provide evidence that Juxtapid is
intended for new uses, for which it lacks approval and for which its labeling does not provide
adequate directions for use, which renders Juxtapid misbranded within the meaning of the
Federal Food Drug and Cosmetic Act (FD&C Act) and makes its distribution violative of the
FD&C Act. See 21 U.S.C. 352(f)(1), 331(a); 21 CFR 201.5, 201.100, 201.115, 201.128.
Background
Below are the indication and summary of the most serious and most common risks
associated with the use of Juxtapid.
1
According to the INDICATIONS AND USAGE section of the FDA-approved product labeling
(PI) for Juxtapid (emphasis original):
JUXTAPID is indicated as an adjunct to a low-fat diet and other lipid lowering
treatments, including LDL apheresis where available, to reduce low-density lipoprotein
cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-
density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial
hypercholesterolemia (HoFH).
1
This information is for background purposes only and does not necessarily represent the risk information that
should be included in the promotional activities cited in this letter.
Reference ID: 3404255