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Aegerion to pay fine for Juxtapid violations

September 25, 2017 11:18 PM UTC

Aegerion Pharmaceuticals Inc. will pay more than $40 million to the SEC and the U.S. Department of Justice to resolve allegations associated with Juxtapid lomitapide. The drug was approved in the U.S. in 2012 as adjunct therapy to treat homozygous familial hypercholesterolemia (hoFH) with a REMS requiring hepatotoxicity risk warnings and clinical or laboratory diagnosis consistent with the indication.

Aegerion agreed to plead guilty in the U.S. District Court for the District of Massachusetts to two misdemeanor counts of misbranding Juxtapid by failing to comply with the drug's REMS program requirements and inadequate labeling directions for its use. According to the filing, Aegerion failed to give healthcare providers "complete and accurate information," and made diagnosis of hoFH "as vague and indefinite as possible in order to extend the product use to additional patient populations," including heterozygous FH and statin-intolerant patients. The government said the company used a definition of HoFH "that was inconsistent with Aegerion’s pre-approval filings with the FDA and that did not correspond to any peer-reviewed clinical standard for diagnosing HoFH." The company also resolved allegations from the DOJ regarding false claims submitted to government healthcare programs and entered into a consent decree of permanent injunction with FDA. ...