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GEN News Highlights : Dec 23, 2010

AstraZeneca and Abbott Pull NDA for Lipidemia Drug

Companies received a complete response letter in March for Certriad, which combines Crestor and Trilipix.

AstraZeneca and Abbott are ceasing development of the FDA-filed mixed lipidemia therapy candidate Certriad™. The drug is a combination of AstraZeneca’s Crestor (rosuvastatin calcium) and Abbott’s Trilipix (fenofibric acid).

The firms had filed an NDA with FDA for Certriad in June 2009. In March received a complete response letter (CRL) from the agency.

They say the joint decision to drop the drug follows a careful review of the CRL and the resulting regulatory delay, which led them to conclude that development of Certriad is no longer commercially viable.