AstraZeneca and Abbott Submit New Drug Application to the FDA for the Approval of CERTRIAD for the Treatment of Mixed Dyslipidemia
Published date :04 June 2009
AstraZeneca and Abbott announced today 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.
"This 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.
NOTES TO EDITORS:
CERTRIAD is an investigational compound under joint development by AstraZeneca and Abbott for the treatment of mixed dyslipidemia. Phase III data for CERTRIAD have been presented and evaluate the efficacy and safety of this therapy in improving HDL-C and triglycerides compared to rosuvastatin monotherapy, and improving LDL-C compared to fenofibric acid monotherapy in patients with mixed dyslipidemia.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at www.abbott.com.