Aegerion Pharmaceuticals disclosed these days that it is becoming investigated by the US Division of Justice in excess of its marketing of Juxtapid (lomitapide). The drug was approved in December 2012 to help further lower cholesterol in sufferers with homozygous familial hypercholesterolemia. The drug charges $ 250,000 a yr. The approval came with a box warning about the chance of hepatotoxicity and a strict Risk Evaluation and Mitigation Strategy (REMS) Program which requires certification of well being care suppliers and pharmacies prior to the drug can be prescribed and dispensed.
Last November the company received a warning letter from the FDA after Aegerion’s CEO, Mark Beer, produced feedback on CNBC improperly promoting the drug. Adam Feurstein reported on The Street:
In the course of interviews on CNBC’s ”Fast Money” plan, Beer suggesting remedy with Juxtapid prevents heart attacks and extends the lives of sufferers with familial homozygous hyercholesterolemia (HoFH), a unusual genetic ailment which leads to the build up of incredibly higher ranges of cholesterol in the blood.
The FDA approved Juxtapid based on clinical trials displaying the pill lowers cholesterol levels in HoFH sufferers only. The research did not demonstrate Juxtapid minimizes the danger of heart attacks or aids HoFH patients live longer.
Aegerion stated it will entirely cooperate with the DOJ investigation.
Hat tip: Marilyn Mann
Justice Department Investigating Aegerion More than Marketing Of New Cholesterol Drug
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