Byetta gets FDA OK for use with TZD

US drug firms Amylin Pharmaceuticals and Eli Lilly say that their co-developed diabetes drug Byetta (exenatide) has been approved by the FDA as an adjunctive therapy for blood sugar control in diabetic patients. Specifically, the agent has been cleared for use by type 2 diabetes sufferers who have not achieved adequate control while receiving thiazolidinedione-based treatment.

The announcement adds to the list of currently-available diabetes therapies with which the drug can be combined, following the FDA's approval for its use with metformin and sulfonylurea-based drugs in 2005 (Marketletter May 9, 2005).

The companies added that the FDA's decision is based on the findings of a clinical trial that evaluated the product plus combined thiazolidinedione (TZD) in patients with the condition. The results showed that 62% of those who received that treatment achieved A1C levels of 7% or less, versus only 16% of the placebo group. In addition, those treated with the drug lost an average of 3.3 pounds in weight over the study's 16-week duration, compared with an average loss of 0.4 pounds in the control group.