MannKind Corporation (NASDAQ:MNKD) saw its shares rise after the U.S. Food and Drug Administration approved a revision to the prescribing information for Afrezza, the companys inhaled insulin product for adults with diabetes.
The updated label aims to give clinicians clearer direction on starting Afrezza dosages when converting patients from subcutaneous mealtime insulin regimens. That includes guidance for patients moving from either multiple daily injections or insulin pump bolus dosing to inhaled insulin.
"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.
Specific conversion recommendations are now included in the label. As an example provided by the company, patients taking up to 3 units of injected mealtime insulin would initiate Afrezza at 4 units, while those on 8 or more units of injected mealtime insulin would begin at 16 units of the inhaled product.
MannKind said the revised dosing guidance is supported by modeling analyses and by in vivo evidence from its Dose Optimization study and the INHALE-3 trial. According to the company, those data sets showed improved postprandial glucose outcomes after patients were converted to inhaled insulin using the conversion doses now reflected in the label.
Afrezza is an FDA-approved inhaled insulin therapy intended for use by adults with diabetes. The label change focuses strictly on starting-dose conversion guidance when moving patients from injected mealtime insulin or pump bolus dosing to Afrezza.
The approval and accompanying dose-conversion guidance may affect prescribing patterns among clinicians treating adults with diabetes who are considering an inhaled insulin alternative to subcutaneous mealtime insulin. The immediate market reaction included an intraday increase in MannKind stock value following the announcement.
Sector impact: The update is principally relevant to the healthcare and biotech sectors, particularly companies involved in diabetes therapeutics and drug delivery technologies.