Abbott, AstraZeneca Submit NDA For CERTRIAD

Abbott and AstraZeneca have announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA). It is for an investigational compound 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 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 FDA approval, the treatment will be marketed as Certriad.

Howard Hutchinson, Chief Medical Officer of AstraZeneca, said: The NDA submission is an important milestone in the development of CERTRIAD and demonstrates our commitment to developing treatments for dyslipidemia.

We look forward to continued discussions with the FDA about this potential new medicine, he added.