FDAnews Drug Daily Bulletin

ASTRAZENECA DISCONTINUES DEVELOPMENT OF GALIDA

May 15, 2006
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AstraZeneca is discontinuing development of Galida, a type 2 diabetes treatment, because it could not find evidence that the treatment was appreciably better than current therapy.

Following analysis and interpretation of recently obtained results from the first four of eight Phase III clinical trials (Gallant 6,7,8 and 9) and one Phase II trial (Armor), which were reviewed in consultation with external experts, the company considers that the overall benefit / risk profile is unlikely to offer patients significant advantage over currently available therapy.

Central to the decision is data showing elevations in serum creatinine and an associated decrease in Glomerular Filtration Rate. The magnitude of the serum creatinine elevation was greater than anticipated based on earlier clinical studies. Such elevations reversed towards baseline upon stopping treatment with the drug and have not been associated with kidney toxicity.

Galida is a dual Peroxisome proliferator-activated receptors (PPARs) alpha and gamma agonist and was in phase III development for the treatment of the glucose and lipid abnormalities associated with type 2 diabetes.