Symlin Approval For Type 1 Diabetes Less Risky Than Potential Off-Label Use, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Off-label use for type 1 diabetes could endanger patients due to higher risk of severe hypoglycemia in type 1 disease if pramlintide were approved only for type 2 diabetes, FDA review documents show. Lengthy NDA review illustrates difficulty of designing trials in the context of insulin use, where benefit is tied to risk.