Abbott received USFDA approval for Simcor (Niaspan/Simvastatin)

Abbott has received USFDA approval for Simcor, the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan (Abbott's proprietary niacin extended-release) and simvastatin. Simcor is a combination of two existing, approved treatments: simvastatin, a statin, and Abbott's Niaspan, an extended-release version of niacin, a B vitamin. Simcor's approval is the first for a cholesterol drug since questions cropped up about the effectiveness of another treatment, Merck and Shering plough Corp.'s Vytorin, and could augur well for FDA approval of Merck's Cordaptive cholesterol-lowering drug, which also is based on niacin. The FDA's 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 clinical trial, patients receiving Simcor 1000/20mg achieved significant cholesterol improvements over and above what simvastatin 20 mg alone provided. Patients treated with Simcor 1000/20mg had additional lipid improvements beyond simvastatin 20-mg treated baseline, with additional LDL reductions of 12 per cent and an additional 21 percent HDL increase compared to a 7 per cent decrease in LDL and an 8 per cent increase in HDL with simvastatin 20mg alone. Furthermore, Simcor reduced triglycerides by an additional 27 per cent compared to 15 per cent with simvastatin 20 mg alone.
Abbott said it is performing a study investigating whether Simcor is better than simvastatin or Niaspan alone, but results won't be available until 2011.