MannKind Corp. today announced that the U.S. Food & Drug Administration has updated prescribing information for Afrezza, the company’s sole commercial product. News of the updated FDA label sent the company’s stock up more than 7 percent.
The Westlake Village biotech company’s Afrezza is an inhalable insulin for both Type 1 and Type 2 diabetes. The updated prescribing information will help Afrezza move into the Type 2 diabetes market, which is much larger than the Type 1 market, where most of its sales now occur, Chief Executive Michael Castagna said during a conference call Monday to explain the label change.
The update also includes dosage strength over time and clarity around mealtime dose guidelines. The label has also been updated with a pregnancy and lactation section, according to FDA guidance.
“This label update supports Afrezza as a unique fast-acting mealtime insulin that provides doctors and patients with the flexibility necessary to help them achieve glycemic control,” Castagna said in a statement.
Shares of MannKind (MKND) on Monday closed up 17 cents, or 7.8 percent, at $2.34 on the Nasdaq.