MannKind (NASDAQ:MNKD) received U.S. Food and Drug Administration approval on Monday for a critical update to the prescribing information for Afrezza, its inhaled mealtime insulin.
The revision provides the first formal "starting dose" conversion table for adult patients switching from subcutaneous injections or insulin pumps to the inhaled powder.
The updated label addresses a long-standing hurdle for the therapy: the lack of standardized guidance for clinicians when transitioning patients.
Because inhaled insulin has a different absorption profile than liquid injections, the new conversion table suggests a higher initial unit count to achieve comparable glucose-lowering effects.
For example, a patient currently injecting up to 3 units of mealtime insulin is now recommended to start on a 4-unit Afrezza cartridge.
The FDA’s decision was backed by data from the Dose Optimization study and the INHALE-3 trial.
Those studies demonstrated that using these specific conversion ratios resulted in significantly improved postprandial glucose (post-meal sugar) outcomes.
Clinical results showed that Afrezza reached peak insulin levels in approximately 12 minutes—mimicking the body’s natural response more closely than many rapid-acting analogs.
"We expect that this label update will help support healthcare providers by providing clearer starting dose guidance when transitioning patients," said Dr. Kevin Kaiserman, Senior Vice President and Therapeutic Area Head of Diabetes at MannKind.
The regulatory win comes at a pivotal moment for the Danbury, Connecticut-based firm.
MannKind is currently awaiting a separate FDA decision, expected by May 29, 2026, regarding the use of Afrezza in pediatric patients.
If approved, it would mark the first needle-free insulin option for children in over a century.