The FDA has approved Abbott’s Simcor, the first fixed-dose combination of two cholesterol therapies, Niaspan (niacin) and simvastatin.
Simcor has been approved for use along with diet to lower levels of elevated total cholesterol, LDL cholesterol and triglycerides and to raise HDL cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not considered adequate, according to the Abbott Park, Ill.-based company.
The approval was based on safety and efficacy trial data from more than 640 patients with mixed dyslipidemia and Type II hyperlipidemia, the company said.
In the SEACOAST clinical trial, Simcor reduced triglycerides by an additional 27% compared to 15% with simvastatin 20mg alone, Abbott said.
"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 lead Simcor investigator Christie Ballantyne, MD, from the Methodist DeBakey Heart and Vascular Center in Houston.