MannKind pushes for FDA approval in 2025 amid diabetes treatment controversy

In the United States, MannKind Corporation disclosed the results of the Phase 3 INHALE-1 study involving its inhaled insulin product, Afrezza, specifically targeting children and adolescents aged 4 to 17 years. The study reported its findings after a six-month treatment period, highlighting significant results that could reshape diabetes treatment for younger patients. Notably, findings indicated that while the primary intent-to-treat population analysis showed that the change in mean HbA1c levels surpassed the predetermined non-inferiority margin, a modified intention-to-treat analysis revealed a non-inferiority result for Afrezza against multiple daily injections (MDI) of insulin. This analysis took the exclusion of one outlier into account, which reflects the potential variability that can arise in clinical trials due to patient compliance. Further insights from the trial indicated that there were no considerable differences in lung function metrics between the Afrezza group and those receiving MDI, with both groups demonstrating normal lung function measures throughout the study duration. The company emphasized the ongoing importance of evaluating potential adverse effects, citing that common responses such as hypoglycemia, cough, and throat discomfort were observed but not significantly more prevalent in either treatment cohort. Additionally, the ongoing 26-week extension phase involves switching remaining MDI patients to Afrezza, suggesting a continued commitment to observing treatment impacts over a more extended period. Looking forward, MannKind intends to engage with the U.S. Food and Drug Administration (FDA) to discuss a supplemental New Drug Application (sNDA) for Afrezza, the submission of which is anticipated in the first half of 2025. This forthcoming engagement highlights the company's intentions to expand the range of treatment options for the pediatric population, addressing the long-standing reliance on injectable insulin. The collaboration with prominent researchers, such as Dr. Roy W. Beck, underscores the scientific interest and hopeful outlook towards inhaled insulin as a viable treatment for children with diabetes, who have historically lacked such options. In summary, as MannKind Corporation continues to navigate the complexities of regulatory pathways and clinical findings, the implications of INHALE-1's results could signal a significant step towards diversifying and improving diabetes care for younger patients who struggle with conventional insulin delivery methods. The company maintains a cautious yet optimistic approach, reiterating its commitment to addressing the needs of patients while ensuring safety and efficacy through rigorous clinical evaluation.