AztraZeneca stops the development of Galida

Anglo-Swedish drug major AstraZeneca says that it will discontinue the development of its late-stage diabetes drug Galida (tesaglitazar) following analysis of trial data. The drug, which is a dual peroxisome proliferator-activated receptor alpha and gamma agonist, had reached the stage of Phase III examination as a treatment for glucose and lipid abnormalities associated with type II diabetes.

Data review focuses on risk/benefit profile

In the analysis of data derived from four Phase III clinical assessments of the drug (named GALLANT 6,7,8 and 9) and from the ARMOR Phase II study, a group of external experts concluded that the compound's risk benefit /profile is unlikely to offer patients significant advantage over currently-available therapy. Specifically, the panel highlighted data showing elevated serum creatine levels and an associated decrease in glomerular filtration rate, both of which were greater than anticipated based on the results of earlier clinical assessments (Marketletter June 20, 2005).