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UPDATE: What Amarin Would Need To Disclose To Ensure Non-Misleading Speech

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"To ensure that this speech is non-misleading, Amarin would also disclose the following:
•FDA has not approved to Vascepa reduce the risk of coronary heart disease;
•The effect of Vascepa on the risk of cardiovascular mortality and morbidity has not been determined;
•A cardiovascular outcomes study of Vascepa designed to evaluate the efficacy of Vascepa in reducing cardiovascular mortality and morbidity in a high-risk patient population on statin therapy is currently underway;
•Vascepa may not be eligible for reimbursement under government healthcare programs, such as Medicare or Medicaid, for treatment of statin-treated patients with mixed dyslipidemia and high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels or to reduce the risk of coronary heart disease. We encourage you to check that for yourself; and
•Any potential financial or affiliation biases between the firm and those who conducted the ANCHOR study."

Posted-In: News FDA Legal

 

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