From the FDA approvals of dupilumab and maralixibat tablets to a new puzzler case study, get caught up with our weekly review article.
Weekly review: FDA approves dupilumab, ACIP meets, and more | Image Credit: © Artur - © Artur - stock.adobe.com.
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Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from the week (Monday, April 7, to Friday, April 11, 2025), and click on each link to read and watch anything you may have missed.
On April 18, 2025, the FDA approved dupilumab (Dupixent) for chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older with inadequate response to H1 antihistamines. This marks the first new targeted therapy for CSU in over a decade and expands dupilumab’s indications to seven type 2 inflammatory diseases. Approval was based on the LIBERTY-CUPID phase 3 program, which demonstrated significant reductions in itch and hive severity, with 30% of patients reporting complete response. Safety findings were consistent with dupilumab’s established profile.
Click here for more on dupilumab.
On April 16–17, 2025, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended GSK’s Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) as a single-dose alternative for adolescents aged ≥10 years during routine meningococcal vaccination. Penmenvy, FDA-approved in February 2025, targets the five most common Neisseria meningitidis serogroups. ACIP also recommended Bavarian Nordic’s chikungunya vaccine Vimkunya for individuals aged ≥12 years traveling to outbreak areas. Vimkunya, the first virus-like particle (VLP) single-dose vaccine for chikungunya, showed strong immunogenicity in phase 3 trials. Recommendations await CDC director approval.
On April 14, 2025, the FDA approved a new tablet formulation of maralixibat (Livmarli; Mirum Pharmaceuticals) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged ≥3 months and in those with progressive familial intrahepatic cholestasis (PFIC) aged ≥12 months. Previously available only as an oral solution, the tablet offers dosing flexibility for older patients and is expected to be available in June through the Mirum Access Plus program. Maralixibat was first approved in 2021 for ALGS patients aged ≥1 year and later approved for PFIC patients aged ≥5 years in March 2024, based on data from the ICONIC and MARCH PFIC phase 3 trials, respectively.
These studies demonstrated significant improvements in pruritus, bile acids, bilirubin, and growth outcomes. The expanded formulation provides a more convenient option for managing pruritus in these rare pediatric liver diseases.
Our latest Contemporary Pediatrics poll presents a 2-month-old female with a 3-day history of new-onset scalp swelling. Born via vacuum-assisted vaginal delivery after an uncomplicated pregnancy, the infant had no prior scalp issues beyond transient neonatal swelling. At 8 weeks, a soft, fluctuant subcutaneous fluid collection was noted over the parieto-occipital scalp, without crossing suture lines and with no signs of trauma or systemic illness.
Can you diagnose this patient?
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Findings published in JAMA Network Open from a large Israeli cohort study showed that children breastfed for at least 6 months had significantly lower odds of developmental delays and neurodevelopmental conditions. The study analyzed data from over 570,000 children born between 2014 and 2020, excluding those with severe illness or prolonged neonatal hospitalization. Exclusive breastfeeding was associated with a 27% reduced odds of milestone delays (AOR, 0.73), and nonexclusive breastfeeding showed a 14% reduction (AOR, 0.86).
Results were consistent in a sibling comparison subgroup and across term and late-preterm infants. While causality was not established, the findings underscore the potential developmental benefits of breastfeeding and highlight the need for systemic support to improve breastfeeding practices.
