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FDA committee recommends approval of Pfizer and Sanofi-Aventis’ Exubera

An FDA advisory committee has recommended the approval of Exubera, an inhaled insulin treatment for adults with type 1 and type 2 diabetes, co-developed by Pfizer and Sanofi-Aventis.

Exubera is a form of insulin that is inhaled through the mouth into the lungs prior to eating, using a proprietary inhalation device and powdered insulin formulation developed by Nektar Therapeutics.

Exubera closely mimics the normal physiological insulin response to meals by quickly being absorbed into the bloodstream to reduce meal-related spikes in glucose levels in people with diabetes.

The recommendation makes approval of the drug likely, but the FDA is not obligated to follow the recommendations of the advisory panel.

Pending FDA approval, Exubera would represent a major advance in insulin delivery and would be the first non-injectable insulin available in the US since the discovery of insulin in the 1920s.

In the US, approximately 18 million people suffer from diabetes, with type 2 diabetes accounting for 90% to 95% of all diagnosed cases.