Abbott seeks approval for new cholesterol pill

Simcor contains Niaspan – used to raise HDL “good” cholesterol levels, and simvastatin – used to reduce LDL “bad” cholesterol levels. This combination is being submitted for FDA approval to address LDL, HDL and triglycerides in a single pill, which Abbott hopes will improve patient convenience and outcomes.

The Niaspan/simvastatin application includes data from two large clinical studies, composed of more than 1,150 randomized patients, which evaluated safety and efficacy of the combination of Niaspan and simvastatin in patients with mixed dyslipidemia. These studies measured the additional impact of combining Niaspan and simvastatin on key lipid parameters.

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 billion US cholesterol management market and represents the fastest-growing segment, Abbott said.