Amylin Byetta Antibodies Could Be Root Of Response Variability In Pivotals
This article was originally published in Pharmaceutical Approvals Monthly
Patients showing a poor response to Lilly/Amylin’s type 2 diabetes treatment Byetta have high numbers of antibodies to the incretin mimetic, FDA review documents suggest.
You may also be interested in...
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...
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011