The U.S. FDA approved an update to the prescribing information for Afrezza inhalation powder to treat adults with diabetes mellitus.
Shares of MannKind Corp. (MNKD) gained more than 7% in pre-market trading on Monday after the company announced that the U.S. Food and Drug Administration (FDA) approved an update to the prescribing information for Afrezza, its inhaled mealtime insulin used to improve glycemic control in adult patients with diabetes mellitus.
The revised label provides clearer starting-dose guidance for adult patients switching from multiple daily injections or insulin pump therapy. The update is supported by clinical results from the Dose Optimization study and the INHALE-3 trial, which showed significantly improved post-meal glucose control after conversion to Afrezza, as recommended by the new dosing recommendations.
“We expect that this label update will help support healthcare providers by providing clearer starting dose guidance when transitioning patients to inhaled insulin from subcutaneous mealtime insulin—whether injections or insulin pumps. We believe this refinement to the label helps support appropriate initiation of therapy while reinforcing Afrezza’s established clinical profile,” said Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Diabetes at MannKind Corporation.
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