Update on Inhaled Insulin

Exubera^TM, the powdered inhalable insulin being developed by Pfizer and Sanofi-Aventis was reviewed last Thursday by the FDA’s Endocrinologic & Metabolic Drugs Advisory Committee. The committee backed the drug (and its delivery system: inhalation) as a substitute for some injections.

The FDA has yet to approve it, but often heeds recommendations of its advisory committees. FDA approval may be a year away.

Exubera^TM is the first inhalable insulin to make it this far in the route to FDA approval. Novo Nordisk (with Aradigm) and Eli Lilly (with Alkermes) also have inhalable drugs in development.

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Pfizer's press release:
FDA Advisory Committee Recommends Approval of Exubera® for Use in Adults with Type 1 and 2 Diabetes

Novo Nordisk and Aradigm's press release:
Aradigm Announces Novo Nordisk Presentation of Data of AERx Insulin Diabetes Management System at the American Diabetes Association Annual Meeting

Eli Lilly and Alkermes's press release:
Lilly and Alkermes Initiate Phase 3 Safety Study for Inhaled Insulin