Abbott submits NDA for combination Niaspan/Simvastatin tablet

Apr 24 2007

Abbott has submitted a New Drug Application to the Food and Drug Administration for a fixed-dose combination (Simcor) of Niaspan (extended-release niacin) and simvastatin.

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 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 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 (AHA), more than 38 million Americans have complex lipid disease. Combination therapy makes up 15 percent of the more than $17 billion U.S. cholesterol management market and represents the fastest-growing segment.

"The Niaspan/simvastatin combination tablet is a promising next step in our efforts to develop therapies that support more comprehensive cholesterol management with one pill," said Eugene Sun, M.D., vice president of Global Clinical Development, Abbott. "Combination lipid therapies are an increasing trend to help physicians reach their patients' treatment goals."

Treatment guidelines endorsed by the National Cholesterol Education Panel (NCEP), the American College of Cardiology and AHA have called for more aggressive treatment of lipids, including a lower LDL goal for many patients, as well as more aggressive treatment of HDL and triglycerides. Elevated cholesterol can build up in the bloodstream, forming plaque and restricting blood flow, which can lead to heart disease. According to the NCEP guidelines, reducing LDL cholesterol by 1 percent is associated with a 1 percent reduction of the risk of coronary events, and improving HDL by an increase of one point is associated with a 2 percent reduction in the risk of coronary events.

"More and more, physicians and their patients understand that good cholesterol management means trying to bring multiple parameters into optimal levels for improved cardiovascular health," said James M. McKenney, PharmD, president and CEO of National Clinical Research, and professor emeritus, Virginia Commonwealth University School of Pharmacy in Richmond, VA. "Continued study of managing key lipid parameters is important to advancing heart health."