TL/DR –
MannKind Corporation has announced new clinical and real-world data related to Afrezza, an ultra rapid-acting inhaled insulin approved for glycemic control in children, adolescent, and adult patients with diabetes. The data reinforces the safety and efficacy of Afrezza, highlighting benefits beyond glycemic control and into patients’ daily lives. The key findings include greater treatment satisfaction with inhaled insulin vs. rapid‑acting analogs, comparable efficacy of inhaled insulin with reduced postprandial glucose excursions and fewer hypoglycemic events compared to rapid-acting analog insulin in gestational diabetes, and a potential for earlier post-meal dosing decisions with reduced risk of insulin stacking.
MannKind Corporation Announces Significant Clinical and Real-World Data on Diabetes Treatment
MannKind Corporation, a biopharmaceutical firm focused on innovative solutions for chronic disease care, has announced the upcoming presentation of new clinical and real-world data on Afrezza® and FUROSCIX®. The findings relate to their use in treating cardiometabolic and orphan lung diseases. They will be showcased at the American Diabetes Association’s (ADA) 2026 Scientific Sessions from June 5-8, 2026, in New Orleans, Louisiana.
The announcement comes in the wake of the recent FDA approval on May 29, 2026, of Afrezza for children and adolescents aged 6 and older with type 1 and type 2 diabetes. The new data, highlighting pediatric safety, glycemic control, and treatment satisfaction, further affirm the safety and efficacy of Afrezza.
Dr. Kevin Kaiserman, Senior Vice President and Therapeutic Area Head-Diabetes for MannKind Corporation, highlighted the company’s commitment to expanding meaningful treatment options. He said, “We are committed to expanding meaningful treatment options that can help people better manage their diabetes in a way that works for them, and the growing body of evidence for Afrezza supports a more individualized and patient-centered approach to care.”
Key Findings from the Data
The data includes an exploratory analysis of inhaled insulin used with AID systems, providing insight on the impact of total daily dose algorithms. Additionally, findings from a randomized cross-over trial support the safety and effectiveness of inhaled insulin as an alternative to Rapid-Acting Analogs (RAA) in gestational diabetes.
Data from the INHALE-1 study revealed that pediatric participants treated with inhaled insulin reported greater improvements in treatment satisfaction compared to RAA. The trial also demonstrated non-inferior mean HbA1c in patients treated with inhaled insulin compared with RAA after 26 weeks.
Moreover, an interim analysis indicated comparable efficacy of inhaled insulin and RAA in individuals with gestational diabetes. Inhaled insulin resulted in nominally reduced postprandial glucose excursions and fewer hypoglycemic events compared to RAA. These findings support further investigation of inhaled insulin as a potential alternative in this patient population.
Additional Presentations
MannKind also presented several analyses further characterizing inhaled insulin and FUROSCIX across clinical and real-world settings. These include dosing strategies and postprandial glucose control in adults with type 1 diabetes, and the impact of the Inflation Reduction Act on access to Afrezza, with increased Medicare Part D utilization following the implementation of the insulin cost cap.
Furthermore, a real-world evidence study evaluated the risk of lung cancer among adults with type 2 diabetes, showing no increased incidence among inhaled insulin users compared with other insulin treatment cohorts. Research findings also indicated that treatment with FUROSCIX showed lower rates of hospitalization and longer time to hospitalizations in patients with diabetes experiencing fluid overload due to heart failure.
About Afrezza and FUROSCIX
Afrezza® is an ultra rapid-acting inhaled insulin approved by the U.S. Food and Drug Administration to improve glycemic control in children, adolescents, and adults with diabetes mellitus. It is administered using a small, portable inhaler and delivers insulin via MannKind’s proprietary Technosphere® technology, enabling ultra-rapid absorption through the lungs.
FUROSCIX® is intended for the treatment of edema in pediatric patients who weigh at least 43 kg and adult patients with chronic heart failure or chronic kidney disease, including the nephrotic syndrome.
Michael Castagna, Chief Executive Officer of MannKind Corporation, expressed the company’s commitment to expanding treatment options for people aged 6 and older living with diabetes. He said, “As we look ahead, we remain focused on advancing our pipeline, broadening access, and delivering therapies that better align with the real-world needs of patients.”
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