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Lilly/Amylin submit exenatide

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly/Amylin plan to position their type 2 diabetes agent exenatide for use in patients not achieving goal on oral agents; an NDA for the first-in-class incretin mimetic was submitted June 30. "The initial target population for exenatide does not include patients on insulin," Lilly says. Based on exenatide's novel mechanism, the firms are highlighting its potential as an insulin alternative "that carries a lower risk of hypoglycemia with no weight gain." A National Institutes of Health-sponsored study of exenatide in type 1 diabetes is underway. "The results of that [20-month] exploratory study will determine our next steps in the type 1 diabetes arena," Lilly says...

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