MannKind Corporation Seeks FDA Approval for Pediatric Use of Afrezza

MannKind Corporation (MNKD) is seeking FDA approval for Afrezza, a rapid-acting inhaled insulin, to be used in pediatric patients aged 4-17. The company's pipeline includes therapies for rare lung conditions. MNKD secured up to $500 million in non-dilutive financing to support the pediatric rollout, expand commercial capabilities, and accelerate clinical programs. The US-based manufacturing facility supports revenue generation and pipeline production.

MannKind Corporation (MNKD) is making significant strides in its quest to expand the use of its rapid-acting inhaled insulin, Afrezza, to pediatric patients aged 4-17. The company has submitted a supplemental Biologics License Application (sBLA) to the FDA for a pediatric indication, based on promising data from the INHALE-1 study led by Michael Haller, MD, professor and chief of Pediatric Endocrinology at the University of Florida [1]. The study demonstrated the safety and effectiveness of inhaled insulin in children with type 1 diabetes (T1D).

MannKind has also secured up to $500 million in non-dilutive financing to support the pediatric rollout, expand commercial capabilities, and accelerate clinical programs. This funding will be instrumental in advancing the company's pipeline, which includes therapies for rare lung conditions. The US-based manufacturing facility will continue to play a crucial role in revenue generation and pipeline production [2].

Dr. Haller anticipates an increase in the use of inhaled insulin among pediatric patients with T1D, as it offers a convenient and effective alternative to traditional injection methods. He emphasizes the importance of general pediatricians being aware of this treatment option to better serve their patients [1].

MannKind's focus on expanding the use of Afrezza in pediatric patients is a strategic move that could significantly impact the diabetes treatment landscape. The company's commitment to innovation and patient-centered care is evident in its efforts to secure FDA approval and provide financing for clinical programs.

References:
[1] Fitch J. Michael Haller, MD, discusses inhaled insulin and Afrezza data for type 1 diabetes. Contemporary Pediatrics. August 7, 2025. Accessed August 20, 2025. https://www.contemporarypediatrics.com/view/michael-haller-md-discusses-inhaled-insulin-and-afrezza-data-for-type-1-diabetes
[2] MannKind Corporation reports second quarter 2025 financial results and provides business update. MannKind Corporation. Press release. August 6, 2025. Accessed August 7, 2025. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-corporation-reports-second-quarter-2025-financial