Aegerion Resolves FDA's Warning on Juxtapid, Lifts Overhang


Aegerion Pharmaceuticals, Inc. (AEGR) 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 Juxtapid’s use.

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.

Our Take

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. (GILD), Amgen Inc. (AMGN) and Regado Biosciences, Inc. (RGDO). All these stocks carry a Zacks Rank #1 (Strong Buy).

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