FDA gives Pioglitazone priority review status
While the Food and Drug Administration (FDA) is considering serious side effects of troglitazone, it has given priority review status to pioglitazone, another drug in the same class, thiazolidinediones (TZDs), which work by reducing insulin resistance and taking the stress off the pancreas.
Pioglitazone, developed by Takeda America Research and Development Center of Princeton, NJ, will be marketed in the United States by Eli Lilly and Co., under the brand name ACTOS.
Pioglitazone has been studied in human trials in the United States involving 2,500 subjects to date.
"Clinical studies indicate that ACTOS improves glycemic control in terms of fasting blood glucose and hemoglobin A1c," says Roberta L. Schneider, MD, Takeda’s vice president for drug development and lead clinical researcher in the Princeton headquarters.
Schneider says ACTOS attacks insulin resistance, which "offers a more logical approach to treatment than many other therapies."
In January, the FDA granted priority review to rosiglitazone, another drug in the TZD class being developed by SmithKline Beecham under the brand name Avandia.
[Eli Lilly and Co. can be reached at (317) 277-1172. Contact Roberta Schneider at (202) 261-2873.]
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