Byetta sNDA for TZD combo use
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lilly and Amylin submit an sNDA for the use of incretin mimetic Byetta (exenatide) as add-on therapy to thiazolidinediones (TZDs) in people with type 2 diabetes, the firms announce March 1. The filing comes ahead of schedule: Amylin previously had predicted a mid-2006 filing of the supplement (1Pharmaceutical Approvals Monthly January 2006, p. 28). In the pivotal trial supporting the sNDA, 62% of Byetta-treated patients with baseline A1C over 7% reduced their A1C to 7% or less compared to 16% of similar placebo patients...
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