MannKind’s Afrezza Inhaled Insulin Drug Gets FDA Approval

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.

ALSO READ: America’s Most Profitable Products