AstraZeneca files Crestor/TriLipix combination
This article was originally published in Scrip
AstraZeneca and Abbott have filed a US NDA for Certriad, a combination of AstraZeneca's Crestor (rosuvastatin calcium) and Abbott's TriLipix (fenofibric acid), for the treatment of mixed dyslipidaemia. The two firms have also entered into a co-promotion agreement for TriLipix, further strengthening the ties between them in the cardiovascular area – they already have an agreement whereby Abbott co-promotes Crestor in the US.
AstraZeneca says the new filing for Certriad is supported by data from multiple clinical studies including efficacy and safety studies with 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid. Mixed dyslipidaemia is diagnosed when patients have a combination of two or more lipid abnormalities including high LDL-cholesterol, high triglycerides and low HDL-cholesterol. Crestor (which is licensed from Shionogi) acts to reduce LDL-cholesterol and triglycerides while fenofibric acid also acts to raise HDL-cholesterol. The American Heart Association says that 34 million of the 100 million adults in the US with dyslipidaemia have the mixed form of the disease.
TriLipix was approved in the US in December, when it became the first fibrate with a label that included use both as a monotherapy and in combination with a statin. As such, this approval should help pave the way for approval of the combination product. AstraZeneca said that its current agreement with Abbott for Certriad only applies in the US.
Financial details of the new co-promotion agreement for TriLipix have not been disclosed, but under it, AstraZeneca will obtain the non-exclusive right to co-promote TriLipix alongside Abbott in the US, excluding Puerto Rico. The product is already co-promoted in the US with Solvay Pharmaceuticals which has rights to it for countries outside the US, and is preparing further regulatory filings.