Abbott submits application for cholesterol drug

Abbott and AstraZeneca announced that they have submitted a new drug application to the U.S. Food and Drug Administration for the treatment of dyslipidemia.

The investigational compound is for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL- cholesterol, high triglycerides and low HDL-cholesterol.

The drug, containing the active ingredients of Crestor (rosuvastatin calcium) and Trilipix (fenofibric acid) is supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid. Pending approval of the NDA, the treatment will be marketed as Certriad.

"The NDA submission is an important milestone in the development of Certriad and demonstrates our commitment to developing treatments for dyslipidemia," said Howard Hutchinson, chief medical officer, AstraZeneca.

"Patients with mixed dyslipidemia are an underserved segment of the dyslipidemic population," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott.

According to the American Heart Association, more than 100 million adults in the United States have dyslipidemia. Of those, approximately 34 million people are affected by mixed dyslipidemia.

Daily Herald business writer Kim Mikus contributed.