Abbott and AstraZeneca have submitteda New Drug Application (NDA) to the FDAfor an investigational compound for the treatment of mixed dyslipidemia, acombination of two or more lipid abnormalities including high LDL- cholesterol(the “bad” cholesterol), high triglycerides and low HDL-cholesterol (the”good” cholesterol). The NDA submission for this investigational compound,containing the active ingredients of CRESTOR(R) (rosuvastatin calcium) andTRILIPIX(R) (fenofibric acid), is supported by data from multiple studies,including efficacy and safety studies with the 5mg, 10mg and 20mg doses ofrosuvastatin combined with fenofibric acid. Pending approval of the NDA, thetreatment will be marketed as CERTRIAD(TM). “The NDA submission is an important milestone in the development ofCERTRIAD and demonstrates our commitment to developing treatments fordyslipidemia,” said Howard Hutchinson, chief medical officer, AstraZeneca.”We look forward to continued discussions with the FDA about this potentialnew medicine.” “Patients with mixed dyslipidemia are an underserved segment of thedyslipidemic population,” said Eugene Sun, M.D., vice president, GlobalPharmaceutical Clinical Development, Abbott. “If approved, CERTRIAD couldbecome an important treatment option for physicians looking to providecomprehensive management of mixed dyslipidemia to their patients.”According to the American Heart Association, more than 100 million adultsin the United States have dyslipidemia. Of those, approximately 34 millionpeople are affected by mixed dyslipidemia. Treatment guidelines endorsed bythe National Cholesterol Education Program (NCEP), the American College ofCardiology and the American Heart Association have called for more aggressivemanagement of lipids, including a lower LDL goal for many patients, as well asmore aggressive management of HDL and triglycerides.About CERTRIAD(TM) CERTRIAD is an investigational compound containing the active ingredientsof CRESTOR and TRILIPIX under development by Abbott and AstraZeneca for thetreatment of mixed dyslipidemia. Phase III studies, which have been presentedat multiple scientific forums, were designed to evaluate the effect ofCERTRIAD on HDL and triglycerides compared to rosuvastatin monotherapy and theeffect on LDL compared to fenofibric acid monotherapy in patients with mixeddyslipidemia.
