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Novo/Aradigm inhaled insulin to resume Phase III

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novo Nordisk and Aradigm will resume Phase III trials of their AERx inhaled insulin system in the second quarter, Novo says during its April 28 earnings call. The firms will study both type 1 and type 2 diabetes. In an interim analysis, the insulin Diabetes Management System had shown an unexpected delay in post-meal glucose suppression for type 1 diabetes, prompting Novo to caution that an indication may be limited to type 2. Lilly/Alkermes' AIR is expected to be the next inhaled insulin system to reach the market; Phase III trials in type 2 are underway. Pfizer's Exubera currently is the only inhaled insulin on the market...

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