MannKind Corporation (NASDAQ:MNKD) shares gained 3.5% on Monday after the company said the U.S. Food and Drug Administration has approved changes to the prescribing information for its Afrezza inhaled insulin.
The revised label is intended to give healthcare professionals more explicit guidance on initial dosing when switching patients from subcutaneous mealtime insulin—whether via multiple daily injections or insulin pumps—to inhaled insulin therapy.
“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,” said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Diabetes at MannKind Corporation.
Under the updated recommendations, the label now outlines specific dose-conversion ranges from injected mealtime insulin or insulin pump bolus doses to Afrezza. As an example, patients using up to 3 units of injected mealtime insulin would initiate treatment with 4 units of Afrezza, while those requiring 8 units or more would begin at a 16-unit dose.
MannKind said the label update is supported by pharmacokinetic modeling and in vivo data from its Dose Optimization study as well as the INHALE-3 clinical trial, which showed improved post-meal glucose control when patients were transitioned to inhaled insulin using the newly approved conversion doses.
Afrezza is MannKind’s FDA-approved inhaled insulin therapy for adults with diabetes.