In a government oversight double whammy, Aegerion Pharmaceuticals (NVLN) has plead guilty to FDA charges of misbranding its main revenue-driving drug Juxtapid, while the SEC has charged the company with fraud for the same drug and must pay a $4.1MN penalty.
The dual press releases show a lot of problems with Juxtapid, a cholesterol lowering drug that inhibits its production in the liver. The company promoted the drug for more than what it was approved for by the FDA in order to expand its customer base and failed to disclose various directions for use, circulating incomplete information when it was required to by the FDA's Risk Evaluation and Mitigation Strategy (REMS).
"Rather than following the REMS requirement to distribute Juxtapid only for the narrow indication for which it was approved, Aegerion instead sought to render the diagnosis of homozygous familial hypercholesterolemia (HoFH), a rare disorder that causes high cholesterol levels and early cardiovascular disease, as vague and indefinite as possible in order to extend the product use to additional patient populations," the filing reads, "Aegerion failed to give health care providers complete and accurate information about HoFH and how to properly diagnose it."
Meanwhile the SEC is requiring the company pay a $4.1MN penalty for misleading investors and exaggerating new patient numbers to the drug.
"Aegerion told investors that the number of unfilled prescriptions for Juxtapid was not material and the 'vast majority' of patients receiving prescriptions ultimately purchased the drug. The SEC alleges that Aegerion's records reflect that it was actually around 50 percent of prescriptions that resulted in actual drug purchases." states the release.
The SEC notes that Juxtapid was priced at anywhere from $250,000-$300,000 a patient back in 2013-2014, which is a lot of money to lie about in investor meetings when you're making up 50% of the patients. By 2014, Aegerion had starting disclosing more resonable numbers, with a 50-60% conversion rate.
Aegerion Pharmaceuticals is a subsidiary of Novelion Therapeutics Inc., and Juxtapid was approved by the FDA in December 2012.
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