The US Food and Drug Administration advisory committee has recommended the approval of Exubera (insulin [rDNA origin] powder for oral inhalation), an inhalable, rapid-acting, dry powder insulin for the treatment of adults with type 1 and type 2 diabetes.
Exubera, a joint-development program between sanofi-aventis and Pfizer, 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.
Pfizer and sanofi-aventis said that the companies would continue to work with the FDA to make Exubera available for patients in need. Pending FDA approval, Exubera would represent a major advance in insulin delivery and would be the first non-injectable insulin available in the United States since the discovery of insulin in the 1920s.