MannKind NASDAQ: MNKD said the U.S. Food and Drug Administration has approved Afrezza for pediatric patients with diabetes ages 6 and older, expanding the inhaled mealtime insulin’s label into children and adolescents.
Chief Executive Officer Michael Castagna called the decision “a truly historic moment” for the company and the diabetes community during a conference call held May 29, 2026. Castagna said the approval covers approximately 95% of children diagnosed with type 1 diabetes and represents “the first alternative to mealtime injections in 100+ years of pediatric treatments.”
Castagna said MannKind intends to make Afrezza available for $35 for anyone under age 23, regardless of insurance coverage. He said the company wants to remove barriers to access and noted that the pediatric population is largely covered by commercial insurance and Medicaid.
“As a pharmacist by trade, I can tell you that cost at the pharmacy counter is one of the biggest barriers for families trying a new therapy,” Castagna said. “We’re removing this potential barrier upfront.”
Company Highlights Afrezza’s Mealtime Profile
Castagna emphasized Afrezza’s pharmacokinetic profile, saying the product peaks at about 45 minutes and clears around two hours, which he said more closely mirrors the insulin response of a healthy pancreas than injectable rapid-acting insulin. He contrasted that with injectable mealtime insulin, which he said does not begin to have significant glucose-lowering effect until later and can continue acting after food has been absorbed.
He said this mismatch has been “the single biggest challenge of mealtime control in both adults and pediatrics,” and argued that Afrezza can help bring insulin action closer to real-time eating.
Castagna also referenced adult data from the INHALE-3 trial, saying Afrezza reduced postprandial glucose excursions by more than 35% versus multiple daily injections over the first two hours in a meal challenge. He said pediatric meal challenge data from INHALE-1 showed a peak glucose excursion consistent with what was observed in adults.
INHALE-1 Pediatric Data Reviewed
Dr. Kevin Kaiserman, MannKind’s senior vice president and therapeutic area head for diabetes, said children and adolescents with diabetes face barriers including missed doses, changing insulin sensitivity, irregular eating patterns, discomfort with injections or pump site activity in public, fear of hypoglycemia and treatment fatigue.
Kaiserman reviewed INHALE-1, a phase 3 open-label randomized controlled trial in youth ages 4 to 17 with type 1 or type 2 diabetes across 38 U.S. sites. The trial randomized 230 subjects, with 117 assigned to Afrezza plus basal insulin and 113 to rapid-acting injectable insulin plus basal insulin. Both groups used Dexcom G6 continuous glucose monitoring.
He said the primary endpoint was nominally missed, driven by one subject with a very high A1C who was documented as non-adherent to therapy. After removing that subject, Kaiserman said a sensitivity analysis met the non-inferiority margin.
Kaiserman said Afrezza showed no change in body mass index percentile over 26 weeks, while the rapid-acting insulin analog group had a 3.6% increase, a statistically significant difference between groups. He also said teens and parents reported significantly improved treatment satisfaction with Afrezza compared with subcutaneous insulin.
On pulmonary safety, Kaiserman said there was no difference in change in percent predicted FEV1 between the Afrezza and rapid-acting insulin analog groups over the full study period. After week 26, all subjects used inhaled insulin, and he said those who switched from subcutaneous insulin to Afrezza showed no change in percent predicted FEV1 over the following six months.
Launch Focuses on Pediatric Type 1 Diabetes
Castagna said MannKind’s initial launch focus will be pediatric type 1 diabetes. He cited approximately 360,000 children and young adults ages 6 to 22 living with type 1 diabetes and about 30,000 newly diagnosed patients each year. He said the company includes patients up to age 22 because many remain under the care of pediatric endocrinologists through college.
The company is targeting a concentrated pediatric endocrinology market of roughly 60 key institutions and about 1,000 prescribers that treat the majority of pediatric patients. Castagna said 38 of those top 60 centers participated in MannKind’s clinical trial.
President Nick Marasco said the company has deployed key account managers, medical science liaisons and patient navigators to support prescribers and patients. He said the company is also focusing on education for parents, children, certified diabetes educators and school nurses.
Castagna said MannKind has created starter kits with FEV1 testing devices for point-of-care spirometry and built tools including an online dosing calculator, prescriber portal, electronic medical record integration and pre-printed forms to simplify prescribing.
Market Opportunity and Future Development
Castagna said MannKind’s market research suggests two-thirds of pediatric endocrinologists are likely to prescribe Afrezza, with about half citing elimination of mealtime injections as a primary driver. He said the company sees potential patient share in pediatrics ranging from 23% to 37%, representing an opportunity of $300 million to $500 million in revenue from pediatrics over time.
In response to analyst questions, Castagna said pediatric sales should begin laying a foundation in June, build in the third and fourth quarters and position the company for 2027. He said payer discussions have been positive, with potential formulary improvements around Oct. 1 and Jan. 1.
Castagna also outlined a longer-term Afrezza roadmap, including:
- A 2-unit cartridge, which MannKind expects to file with the FDA by year-end;
- The INHALE-Q digital ecosystem to detect and track Afrezza dosing alongside CGM data;
- Higher-concentration Afrezza cartridges that could deliver up to 20 units in a single dose;
- Potential global expansion following the pediatric approval and progress on long-term safety requirements.
Castagna said the company will have a significant presence at the American Diabetes Association Scientific Sessions, including nine poster presentations and educational programs. He said MannKind will also attend the Jefferies Healthcare Conference in New York the following week.
About MannKind NASDAQ: MNKD
MannKind Corporation, a biopharmaceutical company, focuses on the development and commercialization of inhaled therapeutic products for endocrine and orphan lung diseases in the United States. It offers Afrezza, an inhaled insulin used to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults. The company's product pipeline also includes Tyvaso DPI (Treprostinil), an inhalation powder for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease; MNKD-101, a nebulized formulation of clofazimine, for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial lung disease; MNKD-201, a dry-powder formulation of nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF).
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