FDA approves Pfizer's Exubera inhaled insulin

The Food and Drug Administration has approved the first ever inhaled insulin, providing a potential alternative for many of the more than five million US citizens who take insulin injections, and follows European clearance (see page 18)

Made by world drugs giant Pfizer, Exubera is an inhaled powder form of recombinant human insulin (rDNA) approved for the treatment of adult patients with type 1 and type 2 diabetes, which represents the first new insulin delivery option introduced since its discovery in the 1920s.

The FDA noted that the safety and efficacy of Exubera have been studied in approximately 2,500 adult patients. In clinical studies, the agent reached peak insulin concentration more quickly than regular insulins administered by an injection. Peak insulin levels were achieved at 49 minutes with Exubera versus 105 minutes via injection.