Inhalable Insulin May Be Delayed by FDA

Analysts estimate that Exubera, Pfizer's inhalable insulin, may be delayed by the FDA due to what some analysts claim is insufficient long-term testing testing on the effects of the drug on smokers and children.

Exubera is a dry, fine-powdered insulin that is inhaled into the lungs and then absorbed into the bloodstream.

Dr. Bill Canovatchel, senior medical director for Pfizer and the company's team leader for worldwide diabetes, acknowledged that Exubera does not have long-term testing that specifically addresses the drug's effect on smokers and children. But he noted that Pfizer has still done considerable testing.

"We have submitted a rather extensive and comprehensive submission," said Canovatchel.

Dr. Jay Skyler, a University of Miami professor of medicine and an associate director at the Diabetes Research Institute, said that Exubera and other inhaled insulin products could benefit from longer-term studies.

But Skyler said that Exubera still deserved FDA approval. "Inhaled insulin is effective, has no serious health issues and should receive regulatory approval," said Skyler. "I suspect the FDA will examine [Exubera] carefully because it's the first of its kind to go through there, but I think it meets the regulatory hurdles."

via: CNN Money