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Abbott Submits NDA for Cholesterol Combo

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Abbott submitted a NDA to the FDA for a fixed-dose combination of Niaspan (extended-release niacin) and simvastatin (the generic version of Zocor). The combination targets multiple lipid parameters in a single pill.

Niaspan and simvastatin are two widely prescribed medications for treating cholesterol. Niaspan is used to raise HDL “good” cholesterol levels, and simvastatin is effective in reducing LDL “bad” cholesterol levels. This combination addresses 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 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 (AHA), more than 38 million Americans have complex lipid disease. Combination therapy makes up 15% of the more than $17 billion U.S. cholesterol management market and represents the fastest-growing segment.

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