The panelist who voted against approval for type 1diabetes, Dr. David Cooke, clinical director of the division of pediatric endocrinology at Johns Hopkins University, Baltimore, said he was concerned that the risks outweighed the benefits in this group of patients, particularly because of the potential increased risk of cancer. But he said he was more confident about the risk-benefit profile for patients with type 2 diabetes because they would not be exposed to the drug for as long as patients with type 1 diabetes, and that the inhaled insulin may provide some type 2 patients who might otherwise put off taking insulin with a more acceptable and effective option.
The FDA extended the date for completing the review by three months, so the agency can fully review additional information requested from the company, according to a MannKind statement issued April 7.
This article was updated April 7, 2014.