Inhaled Insulin Should be Approved by FDA: Panel
WebMD News Archive
April 2, 2014 -- An inhaled insulin product to treat type 1 and type 2 diabetes should be approved for sale in the United States, a Food and Drug Administration advisory committee said Tuesday.
The panel of outside experts said that the product -- called Afrezza -- is not as effective as injected insulin but would be useful for some patients, The New York Times reported.
"As an inhaled form of insulin, this represents a drug that will serve some patients that are not effectively served by currently available insulin," the committee's acting chairman Dr. Robert Smith, an endocrinologist at Brown University, said after the vote.
The advisory panel's support for Afrezza was somewhat unexpected because an FDA staff review was critical of the product, saying it was marginally effective and possibly risky, The Times reported.
In two previous attempts, the drug failed to win FDA approval and maker MannKind Corporation had to conduct new clinical trials.
The FDA is not required to follow the advice of its advisory panels.