US Food and Drug Administration seeks more information on AstraZeneca’s cholesterol drugBy AP
Tuesday, March 30, 2010
US seeks more detail on Astra cholesterol drug
LONDON — AstraZeneca PLC and Abbott Laboratories said Tuesday that the U.S. Food and Drug Administration has asked for more information about their Certriad cholesterol drug before approving it for sale.
The companies said that FDA has sought more data in a so-called complete response letter (CRL) to their new drug application, which combines their cholesterol pills TriLipix and Crestor.
Abbott’s TriLipix is part of a class of drugs called fibrates that raise “good” HDL cholesterol while reducing triglycerides and “bad” LDL cholesterol. AstraZeneca’s Crestor is a statin drug that lowers bad cholesterol while raising good cholesterol.
Studies conducted by the companies compared the combination pill versus separate treatment with statin and fibrate drugs.
The companies’ application to the FDA seeks approval to treat dyslipidemia, a disorder characterized by elevated cholesterol and triglycerides, a type of fat found in the blood stream. More than 100 million adults in the U.S. have the disorder, according to the American Heart Association.
The companies said they will continue discussions with the FDA to “determine the next steps,” while responding to the request for more information.
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