Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from the week (Monday, August 4, to Friday, August 8, 2025), and click on each link to read and watch anything you may have missed.
A JAMA Network Open analysis of data from 259,623 US adolescents found that between 2005 and 2023, medical use of prescription stimulants for ADHD increased modestly, while nonmedical use declined steadily. Lifetime nonmedical use reached its lowest level in 2023, reversing earlier trends in which misuse exceeded medical use. The largest decreases were seen in twelfth graders, who initially reported the highest rates of nonmedical use.
Researchers noted that most adolescents currently prescribed stimulants had been using them long term, and the rise in medical use did not coincide with an increase in misuse. The authors suggested these findings may ease concerns about diversion but stressed the importance of ongoing monitoring as prescribing trends evolve.
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On August 6, 2025, MannKind Corporation submitted a supplemental Biologics License Application to the FDA for its inhaled insulin Afrezza for a pediatric population indication, with a decision expected early in the fourth quarter of 2025, according to a financial report from the company.1
The filing was based on data from the INHALE-1 study, led by Michael Haller, MD, MS-CI, lead author of the study and professor and chief of Pediatric Endocrinology at the University of Florida. The study evaluated the safety and efficacy of the inhaled insulin regimen as a replacement for rapid-acting meal insulin in children with type 1 diabetes (T1D).
“The primary outcome essentially showed non-inferiority of inhaled insulin compared to rapid-acting injected insulin,” stated Haller in the video above. “This finding is slightly qualified by the inclusion of 1 patient who was highly non-adherent to their insulin regimen and was assigned to the inhaled insulin group. Including this patient in the analysis resulted in a non-significant p-value for non-inferiority. However, in a sensitivity analysis excluding this non-adherent [patient], the inhaled and injected insulin groups showed nearly identical outcomes in terms of hemoglobin A1C.”
Click here to watch our full interview with Michael Haller, MD, MS-CI.
Asthma remains a leading cause of school absenteeism in the US, affecting roughly 3 in every 30 students, with higher rates among low-income populations. Experts note that returning to school can present challenges such as environmental triggers, medication timing issues, and limited access to rescue therapies. Younger children may rely on school staff to recognize symptoms, while older students—especially adolescents—may underreport symptoms or skip controller medications, leading to flares. Stigma, inconsistent communication, and lack of a clear asthma action plan can further complicate management.
Pediatricians play a key role in preparing families for the school year by ensuring students have inhalers, spacers, and written care plans for both home and school. Reviewing triggers, confirming medication refills, and fostering collaboration with school nurses can help maintain asthma control during the day. Practical strategies—such as pacing during physical activity, restarting allergy medications before school begins, and ensuring warm-up and cool-down periods during exercise—can reduce flare-ups. Consistent communication between parents, providers, and schools is essential to keeping children healthy and in class.
On August 6, 2025, the FDA approved tocilizumab-anoh (Avtozma; Celltrion) IV for treating cytokine release syndrome (CRS) in patients aged 2 years and older, aligning it with all indications of its reference drug, tocilizumab (Actemra; Genentech). CRS is a severe immune reaction that can cause widespread inflammation and organ damage. The biosimilar had previously received approvals in January 2025 for conditions including polyarticular and systemic juvenile idiopathic arthritis, rheumatoid arthritis, giant cell arteritis, and COVID-19 in certain hospitalized adults.
Celltrion reported that phase 3 data confirmed the biosimilar’s efficacy, safety, and pharmacokinetics were highly similar to the reference product. The IV formulation is expected to be available in the US on August 31, 2025, with the subcutaneous version to follow at a later, undisclosed date.
Click here for full approval details.
On August 5, 2025, the FDA approved fremanezumab-vfrm (Ajovy; Teva Pharmaceuticals) injection for preventive treatment of episodic migraine in pediatric patients aged 6 years and older who weigh at least 45 kg (99 lb). This is the first approval of a calcitonin gene-related peptide (CGRP) ligand for migraine prevention in children, expanding the drug’s prior adult indication. The approval was supported by phase 3 SPACE trial results showing significant reductions in monthly migraine days compared to placebo, with a safety profile consistent with adult studies. The most common side effects were injection site reactions, while serious hypersensitivity reactions were rare.
Click here for full approval details.