Aegerion Pharmaceuticals, Inc.
) announced that the Office of Prescription Drug Promotion (OPDP)
of the FDA has issued a closeout letter with regard to its
investigation of the company's marketing and sales of Juxtapid in
the U.S. The closeout letter signifies that the issues mentioned in
the FDA's warning letter have been resolved. Aegerion's shares
gained 5.07% following the announcement.
Juxtapid is approved as an adjunct to a low-fat diet and other
lipid-lowering treatments, to reduce low-density lipoprotein
cholesterol, total cholesterol, apolipoprotein B and
non-high-density lipoprotein cholesterol in adults suffering from
homozygous familial hypercholesterolemia (HoFH).
We remind investors that in late 2013, the FDA had served a warning
letter to Aegerion accusing the company of making misleading
statements related to Juxtapid. The statements held that the
product is intended for indications, for which it had not been
approved. Moreover, the product label did not provide adequate
directions for use in those indications. The statements made also
did not convey any of the risks mentioned in the boxed warning for
The OPDP had alleged that the statements made about Juxtapid
suggested that the drug can be safely used as a monotherapy which
contradicts its label. Moreover, the statements projected Juxtapid
as a safe and effective treatment in decreasing cardiovascular
events including heart attacks and strokes and in increasing the
lifespan of HoFH patients. During this period, Aegerion had also
received a request from the U.S. Department of Justice for the
submission of documents and other information related to the
promotion, marketing and sale of Juxtapid in the U.S.
Aegerion stated in the press release issued by it that it has taken
corrective actions with regard to the promotion, marketing and sale
of Juxtapid in the U.S. including the dissemination of a corrective
broadcast on the issue.
Meanwhile, Aegerion intends to submit a new drug application for
Juxtapid in Japanese HoFH patients in mid-2015. Additionally,
Aegerion is looking to conduct a pediatric study on Juxtapid for
HoFH late in 2014.
We believe that the resolution of the FDA's warning letter on
Juxtapid's promotion, marketing and sale has lifted a major
overhang on the company's shares. We expect investor focus to
remain on updates on Juxtapid.
Aegerion carries a Zacks Rank #3 (Hold). Some better-ranked stocks
in the biotech sector are Gilead Sciences Inc. (
), Amgen Inc. (
) and Regado Biosciences, Inc. (
). All these stocks carry a Zacks Rank #1 (Strong Buy).
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