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FDA PANEL ENDORSES INHALED INSULIN

As reported in the New York Times, September 9, an advisory panel to the U.S. Food and Drug Administration (FDA) has voted, 7 to 2, to recommend approval of the inhaled insulin formula Exubera, for use by either type 1 or type 2 diabetics. Exubera is a joint venture between Pfizer, the French firm Sanofi-Aventis, and the California biotechnology researchers Nektar Therapeutics.

There are stipulations. Pfizer proposes the drug not be used by smokers (who respond to inhaled medications differently), and not licensed for use by children. The advisory panel voted that safety had not been established for patients who had both diabetes and lung diseases. Consensus was that adult, non-smoking diabetics with healthy lungs can safely use this insulin.

This is not the final step. The FDA generally, but not always, follows the advice of its advisory committees, and has not yet ruled on this report. Exubera is a lot closer to approval, but not home yet.