Abbott And AstraZeneca Submit New Drug Application To The FDA For CERTRIAD™, An Investigational Treatment For Mixed Dyslipidemia

Main Category: Cholesterol
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Jun 2009 - 5:00 PDT

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Abbott Park, Illinois (NYSE: ABT) and London, UK - Abbott and AstraZeneca announced that the companies have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational compound for the treatment of mixed dyslipidemia, a combination 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® (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. "We look forward to continued discussions with the FDA about this potential new medicine."

"Patients with mixed dyslipidemia are an underserved segment of the dyslipidemic population," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "If approved, CERTRIAD could become an important treatment option for physicians looking to provide comprehensive management of mixed dyslipidemia to their patients."

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. Treatment guidelines endorsed by the National Cholesterol Education Program (NCEP), the American College of Cardiology and the American Heart Association have called for more aggressive management of lipids, including a lower LDL goal for many patients, as well as more aggressive management of HDL and triglycerides.

About CERTRIAD™

CERTRIAD is an investigational compound containing the active ingredients of CRESTOR and TRILIPIX under development by Abbott and AstraZeneca for the treatment of mixed dyslipidemia. Phase III studies, which have been presented at multiple scientific forums, were designed to evaluate the effect of CERTRIAD on HDL and triglycerides compared to rosuvastatin monotherapy and the effect on LDL compared to fenofibric acid monotherapy in patients with mixed dyslipidemia.

About CRESTOR

CRESTOR is indicated as adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia, and to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is not approved to reduce cardiovascular morbidity and mortality. For patients with hyperlipidemia and mixed dyslipidemia, the usual recommended starting dose of CRESTOR is 10 mg. The 40-mg dose of CRESTOR is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20-mg dose of CRESTOR once daily. When initiating statin therapy or switching from another statin therapy, the appropriate CRESTOR starting dose should first be utilized, and only then titrated according to the patient's individualized goal of therapy.

Please see accompanying full Prescribing Information. For more information about CRESTOR, visit www.crestor.com

About TRILIPIX

TRILIPIX (fenofibric acid) delayed-release capsules is a prescription medicine used along with a low-fat and low-cholesterol diet in adults to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol. TRILIPIX can be used alone. It can also be used to lower triglycerides and increase HDL cholesterol in patients with heart disease or who are at risk of heart disease and who are taking a statin medicine to control their LDL cholesterol. TRILIPIX has not been shown to prevent heart disease or heart attacks or stroke more than a statin alone.

About AstraZeneca

AstraZeneca is engaged in the research, development, manufacturing, and marketing of meaningful prescription medicines and in the supply of health care services. AstraZeneca is one of the world's leading pharmaceutical companies with global health care sales of $31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology, and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar health care business.

For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: http://www.astrazeneca-us.com.

References

1 Prescribing Information for CRESTOR. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
2 Data on file, DA-CRS-01.

Source
Abbott Laboratories