Insulin by Inhaler? FDA Panel Votes Yes

An FDA advisory panel voted to approve a new inhaled insulin device for short-term improvement of glycemic control in diabetic patients. The orally administered dry powder formulation can treat both type 1 and type 2 diabetes.

Afrezza (MannKind) is administered within the 20 minutes of beginning a meal and should be used in combination with basal insulin in type 1 diabetics and glucose-lowering medications in type 2 diabetics.
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It was approved 14-0 for type 1 diabetes and 13-1 for type 2 diabetes; the dissenting vote cited pulmonary and lung cancer risk concerns in using the device.

These risks, as well as pulmonary safety of previous inhaled insulin products, were discussed before the voting took place. Lower rates of HbA1c reductions with inhaled insulin versus those with injected insulin in patients with type 1 diabetes were also mentioned.

This is the third attempt to obtain approval for this device—in 2011, the committee cited lack of clinical data and in 2010, the FDA called for more clinical and labeling information.

For this hearing, the manufacturer included the results of a noninferiority study in patients with type 1 diabetes as well as a study on the devices efficacy in patients with type 2 diabetes.

In type 1 diabetics, researchers observed decreases in HbA1c levels by 0.21%, compared with a decrease of 0.40% with an older generation MedTone inhaler.

When compared with injected insulin in type 1 diabetes, a higher rate of discontinuation-of-use was noted due to cough.

Although oral insulin did not perform as well as traditional insulin, panelists noted that the inhaler offered a treatment options for groups unable to use the injectable form—such as individuals with a fear of needles, disabled patients, and those in need of insulin between meals.

In the type 2 study, the inhaler was compared against Technosphere insulin powder, and was found to decrease HbA1c significantly more (-0.82 versus -0.42 percentage points, P<0.0001).

The most commonly observed side effect when using the device was cough. 

–Michael Potts

FDA. Briefing document: endocrinologic and metabolic drugs advisory committee meeting. 2014 Apr 1. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390864.pdf

Accessed April 4, 2014.