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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.

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