MannKind Asks FDA To Approve Inhaled Insulin

VALENCIA, Calif. (AP) — Drug developer MannKind Corp. said Monday it asked the Food and Drug Administration for marketing approval for Afresa, an inhaled insulin powder designed to help diabetes patients control their blood sugar.

MannKind submitted a new drug application for the use of Afresa in adults with type 1 or type 2 diabetes. The drug is intended to control hyperglycemia, or high blood sugar levels.

Afresa is designed to be taken after meals through an inhaler. It is intended to dissolve immediately upon reaching the lungs. MannKind said that allows insulin levels to peak in 12 to 14 minutes, similar to the way insulin is released in non-diabetics.

The company's new drug application covers both the Afresa Inhaler and the drug itself. FDA reviews typically take 10 months.

In aftermarket trading, MannKind shares rose 20 cents, or 6.5 percent, to $3.30. The stock edged up 4 cents to $3.10 during the regular session.