Abbott, AstraZeneca Seek Approval of New Cholesterol Pill

Abbott Laboratories and AstraZeneca PLC have asked the Food and Drug Administration to approve a new drug that combines two of the companies’ cholesterol pills.

Abbott, the maker of TriLipix, and AstraZeneca, the company behind Crestor, say studies show a pill that contains both drugs lowers so-called bad LDL cholesterol and raises good HDL cholesterol. If approved by the FDA, the new drug would be called Certriad, officials said.

With heart disease a leading cause of death in the United States, drugs which reduce cholesterol, a major factor in heart disease, are big business. However, many drugs cause severe adverse reactions and worsened physical conditions of patients. Dangerous drugs are linked to thousands of patient deaths and injuries in the United States each year.

Certriad could be approved to treat dyslipidemia, a condition which causes an increase in cholesterol and fatty deposits in the blood called triglycerides. An estimated 100 million American adults have dyslipidemia.

The proposed drug performed better in a study compared to treatment with fibrate and statin drugs, which are the standard cholesterol-lowering treatment, company officials said.

Crestor and TriLipix are two top-sellers for the drug makers. In 2008, Crestor earned AstraZeneca about $3.6 billion in sales. TriLipix debuted in December 2008 and earned Abbott about $253 million in the first three months of 2009, according to reports. The drug is prescribed along with a related drug, called Tricor.

The FDA has not said how long a decision on Certriad may take.

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