Sunday, September 11, 2005

Update on Inhaled Insulin

ExuberaTM, 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.

ExuberaTM 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.


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