The Food and Drug Administration (FDA) has delayed until July 15th making a decision on whether to allow the inhaled insulin Afrezza entry into the American market.
Manufactured by Valencia, Calif.-based MannKind Corp., Afrezza uses a small inhaler that delivers insulin powder into the lungs. It is aimed at both type 1 and type 2 people with diabetes.
The technology takes advantage of the lungs’ ability to deliver the insulin directly into the bloodstream, bypassing the need to inject the drug.
The FDA’s extension of its review process centers on concerns about possible ill effects on users’ lungs, including the risk of lung cancer. Although an FDA advisory panel recently voted overwhelmingly* to give a thumbs up to marketing Afrezza, it also recommended longer term studies to address the drug’s possible effects on lungs.
If Afrezza is finally approved for U.S. sales, it would be the first inhalable insulin on the American market since 2006 when Exubera was introduced. Produced by Pfizer, the drug failed to catch on among users or prescribers, and Pfizer withdrew it from the U.S. market in 2007.
Mannkind first applied to the FDA to approve Afrezza in 2010. The FDA rejected the application in 2011, calling for additional clinical trials.
Under the three-month delay mandated by the FDA, Mannkind will be required to produce results from all of its Afrezza trials for review by the agency.
* The panel voted 13 to 1 to approve Afrezza for use with type 1 adults, and unanimously to approve it for use with type 2 adults.