MannKind’s Afrezza Inhaled Insulin Drug Gets FDA Approval

Health and Healthcare

Published: June 27, 2014 4:47 pm

Last Updated: April 28, 2020 12:56 am

The U.S. Food and Drug Administration (FDA) late Friday afternoon announced that it has approved Afrezza, a rapid-acting, inhaled insulin power that improves glycemic control in adults with diabetes. The FDA estimates that 25.8 million Americans have diabetes.

The drug is manufactured by MannKind Corp. (NASDAQ: MNKD) and has had its ups and downs in the approval process. In early April the FDA said it would delay its decision for 3 months and MannKind’s stock lost 11%, dropping to around $6.15.

That FDA decision followed by one week the revelation that regulators had voted nearly unanimously to approve the drug for both Type 1 and Type 2 diabetes. That news sent the stock up 80% to around $7.25.

In the announcement an FDA official noted:

Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin. Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels.

The FDA also noted that Afrezza is not a substitute for long-acting insulin, and must be used in combination with long-acting insulin in patients with type 1 diabetes. The drug is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke.

The news has sent MannKind’s shares up 2.9% in after-hours trading to $10.29 in a 52-week range of $3.80 to $11.11. It appears that investors had already priced the good news into the stock.

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