AstraZeneca, Abbott extend drug partnership, submit NDA

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AstraZeneca and Abbott have extended their co-promotional agreement for Trilipix (fenofibric acid), and submitted a new drug application (NDA) to the FDA for Certriad, an investigational compound for the treatment of mixed dyslipidemia.

The NDA submission for this investigational compound, which contains the active ingredients of Crestor (rosuvastatin calcium) and Trilipix, is supported by data from multiple studies, including efficacy and safety studies with the 5 mg, 10 mg and 20 mg doses of rosuvastatin combined with fenofibric acid.

Pending approval of the NDA, the treatment will be marketed as Certriad to treat a combination of two or more lipid abnormalities, including high LDL cholesterol, high triglycerides and low HDL-cholesterol, according to both companies.

Also, the London-based AstraZeneca said it will continue to co-promote Trilipix from the Abbott Park, Ill.-based Abbott. The medication is used alone or in combination with a statin to treat certain lipid disorders. Under the terms of the extended agreement, AstraZeneca will obtain the non-exclusive right to co-promote Trilipix alongside Abbott in the U.S., excluding Puerto Rico. Financial terms were not disclosed.

Trilipix is a prescription medicine that is used along with diet to lower triglycerides and LDL cholesterol, and increase HDL cholesterol, the companies said. Trilipix also is used along with diet to lower triglycerides and increase HDL cholesterol in people who are at high risk of heart disease and are taking a statin medicine to control their LDL cholesterol. However, Trilipix has not been shown to prevent heart attacks or stroke more than a statin alone.