GSK Avandia/insulin approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline's Avandia (rosiglitazone) clears FDA Feb. 27 for use in combination with insulin, based on a 220-patient study showing no cardiovascular safety signal in type 2 diabetes patients. The approval comes two years after GSK received a new label warning about an increased risk of heart failure with the combo regimen. After the label update, the firm successfully lobbied FDA to require a similar revision to Lilly/Takeda's Actos (pioglitazone) labeling, which already carried an approval for use with insulin. GSK's challenge in promoting the new indication will be to reverse clinicians' current impressions about combo use of the thiazolidinedione and insuli