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BioPharmaceutical

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

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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