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The FDA scolded
(AEGR - Get Report)
CEO Marc Beer in a sharply worded
warning letter Friday
for making exaggerated and unsubstantiated claims about the benefits of the company's cholesterol-lowering drug Juxtapid during two separate appearances on
Beer's on-air statements about Juxtapid provided evidence that Aegerion was marketing the drug for unapproved uses -- a "serious" violation of FDA law, regulators said.
During interviews on
"Fast Money" program, Beer suggesting treatment with Juxtapid prevents heart attacks and extends the lives of patients with familial homozygous hyercholesterolemia (HoFH), a rare genetic disease which causes the build up of extremely high levels of cholesterol in the blood.
The FDA approved Juxtapid based on clinical trials showing the pill lowers cholesterol levels in HoFH patients only. The studies did not prove Juxtapid reduces the risk of heart attacks or helps HoFH patients live longer.
One year of Juxtapid therapy costs $250,000. At an investor meeting last week, Beer said the company was "on track to have the most successful launch in the orphan industry" and that Juxtapid peak sales could exceed $1 billion. Juxtapid competes with another HoFH drug, Kynamro, marketed by
(ISIS - Get Report)
and the Genzyme unit of
(SNY - Get Report)
Aegerion has long maintained that the number of patients with HoFH is greater than experts have previously estimated. Not everyone agrees and some question whether Aegerion is marketing Juxtapid to patients who do not have HoFH even if their cholesterol is dangerously high.
It's not uncommon for FDA to call out drug companies for taking liberties with marketing materials, but the agency, in its
, sounded particularly peeved at Beer's mis-statements about Juxtapid.
OPDP [FDA's Office of Prescription Drug Promotion] requests that Aegerion immediately cease misbranding Juxtapid and introducing it into interstate commerce for unapproved uses for which it lacks adequate directions. Please submit a written response to this letter on or before November 22, 2013, stating whether you intend to comply with this request, listing any promotional materials (with the 2253 submission date) for Juxtapid that contain statements such as those described above, and explaining your plan for discontinuing use of such materials or, in the alternative, your plan to cease distribution of Juxtapid. Because the violations described above are serious, we request, further, that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to correct any misimpressions about the approved use of Juxtapid.
In response to the FDA's warning letter, Aegerion issued the following statement:
We take regulatory compliance very seriously and acknowledge that our messaging in any setting, including a media interview as in this particular instance, needs to be accurate and fair balanced. Our plan is to take quick action in response to the FDA's letter and immediately and effectively address any unsuitable language. We appreciate that the FDA's objective is to ensure that promotion is consistent with approved labeling, and in that respect we are aligned with the agency.
Beer appeared on
June 5 and said about Juxtapid: "It's a devastating disease that causes early death. And the drug is corrective against that disease and that's the most important thing. If you think about some oncology products that may lengthen life three months or six months, this product has the potential of taking a patient that would die at 30 and allow them to meet their grandkids."