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FDA Approves Abbott’s Cholesterol Combo Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Abbott received approval from the FDA for Simcor, the first fixed-dose combination of cholesterol therapies, Niaspan (Abbott’s niacin extended-release) and simvastatin. Simcor is approved for use along with diet to lower levels of elevated total cholesterol, LDL “bad” cholesterol and triglycerides, and to raise HDL “good” cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not adequate.
   
“Managing cholesterol encompasses many factors, not just lowering LDL. There is a clear need for medicines that both raise good and comprehensively lower the bad components of cholesterol,” said Christie Ballantyne, M.D., of the Methodist DeBakey Heart and Vascular Center, Houston, and lead Simcor investigator. “Simcor represents an important new option to help patients reach healthy lipid levels.”
   
The approval was based on Simcor safety and efficacy trial data from more than 640 patients with mixed dyslipidemia and type II hyperlipidemia. In the SEACOAST trial, patients receiving Simcor achieved significant cholesterol improvements over simvastatin alone and had additional lipid improvements, with LDL reductions of 12% and an additional 21% HDL increase compared to a 7% decrease and an 8% increase, respectively, with simvastatin alone. Also, Simcor reduced triglycerides by an additional 27% compared to 15% with simvastatin alone.

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