Abbott Labs submits US NDA for Simcor

US health care major Abbott Laboratories has submitted a New Drug Application to the Food and Drug Administration for Simcor, a fixed-dose combination of Niaspan (extended-release niacin) and simvastatin, a product that targets multiple lipid parameters in a single pill.

Niaspan is used to raise high-density lipoprotein cholesterol levels, and simvastatin is effective in reducing low-density lipoprotein cholesterol levels. This combination is being submitted for FDA approval to address LDL, HDL and triglycerides in a single pill, which may lead to improved patient convenience and outcomes.

The application includes data from two large clinical studies, composed of more than 1,150 randomized patients, which evaluated safety and efficacy of the combination in subejcts with mixed dyslipidemia. According to the American Heart Association, more than 38 million Americans have complex lipid disease. Combination therapy makes up 15% of the more than $17.0 billion US cholesterol management market and represents the fastest-growing segment.