More detail on AstraZeneca cholesterol drug sought

AstraZenecaBefore approving Certriad cholesterol drug for sale, AstraZeneca PLC and Abbott Laboratories stated that more information on the drug has been asked by the U.S. Food and Drug Administration.

The FDA sent a complete response letter in which more data regarding their new drug application, which combines their cholesterol pills TriLipix and Crestor has been sought.

Good HDL cholesterol is raised by Abbott's TriLipix being a class of drugs called fibrates and it reduces triglycerides and bad LDL cholesterol. Bad cholesterol is reduced while good cholesterol is raised by AstraZeneca's Crestor, which is a statin drug.

The companies conducted studies in which they compared the combination pill versus separate treatment with statin and fibrate drugs.

Approval to treat dyslipidemia, a disorder characterized by elevated cholesterol and triglycerides, a type of fat found in the blood stream, is being seeked by the companies' application to the FDA.

According to the companies discussions with the FDA would continue to determine the next steps, while responding to the request for more information.