Aegerion Warns About Negative Impact Of DOJ Investigation Reply

Earlier this week in its annual report Aegerion Pharmaceuticals provided an update on its ongoing problems with the FDA and the Department of Justice. As previously reported here and on The Street and on CNBC, the company landed in hot water with the FDA last year after its CEO made a series of off-label statements on the CNBC Fast Money show. (The company’s only product, Juxtapid (lomitapide) is a cholesterol-lowering drug indicated for the rare condition of homozygous familial hypercholesterolemia. It sells for $250,000 a year.) Now the company reports that by running “a corrective advertisement on CNBC” and by reviewing additional promotional material  it believes it will be able to resolve its problems with the FDA.

But the DOJ investigation may prove to be a bigger and more serious problem….

Click here to read the full post on Forbes.

 

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Justice Department Investigating Aegerion Over Marketing Of New Cholesterol Drug Reply

Aegerion Pharmaceuticals disclosed today that it is being investigated by the US Department of Justice over its marketing of Juxtapid (lomitapide). The drug was approved in December 2012 to help further lower cholesterol in patients with homozygous familial hypercholesterolemia. The drug costs $250,000 a year. The approval came with a box warning about the risk of hepatotoxicity and a strict Risk Evaluation and Mitigation Strategy (REMS) Program which requires certification of health care providers and pharmacies before the drug can be prescribed and dispensed.

Last November the company received a warning letter from the FDA after Aegerion’s CEO, Mark Beer, made comments on CNBC improperly promoting the drug.

Click here to read the full post on Forbes.

 

 

FDA Approves Lomitapide For Homozygous Familial Hypercholesterolemia Reply

Aegerion Pharmaceuticals said today that the FDA had approved lomitapide (Juxtapid) to help further lower cholesterol in patients with homozygous familial hypercholesterolemia. The approval comes with a box warning about the risk of hepatotoxicity and a Risk Evaluation and Mitigation Strategy (REMS) Program which will require certification of health care providers and pharmacies before the drug can be prescribed and dispensed. The drug is expected to cost between $200,000-$300,000 per year.

The novel drug, which is a microsomal triglyceride transfer protein inhibitor is indicated, according to the label, “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)” The label notes that the safety and effectiveness of the drug has not been established in hypercholesterolemia patients who do not have homozygous FH and that the effect of the drug on cardiovascular morbidity and mortality has not been determined.

Click here to read the press release from Aegerion…