FDA Approves Dupilumab for Children with Uncontrolled CSU

The FDA has approved dupilumab (Dupixent) as the first biologic medicine for children 2 to 11 with uncontrolled chronic spontaneous urticaria (CSU), according to a news release.¹ This new indication for dupilumab gives pediatric patients who aren’t getting relief from antihistamines alone a more viable treatment option, expanding on a previous indication for patients 12 years and older.

“Children with uncontrolled CSU continue to experience the unpredictable appearance of debilitating itch and hives,” said Alyssa Johnsen, MD, PhD, global therapeutic area head of immunology development at Sanofi, according to the release.¹ “Until now, these patients had to rely on limited treatment options that didn’t address potential critical mediators of CSU.”

Announced on April 22, 2026, this approval addresses a critical unmet need for more than 14,000 children in the US who continue to suffer from debilitating, unpredictable hives and intense itching, despite treatment with standard H1 antihistamines.^1,2

For pharmacists, this expansion signifies a major shift in the therapeutic landscape, moving pediatric CSU management from traditional antihistamine escalation toward targeted immunomodulation.^1-3

READ MORE: FDA Approves Remibrutinib for Adults With Chronic Spontaneous Urticaria

The approval was primarily supported by the LIBERTY-CUPID clinical study, which demonstrated that dupilumab significantly reduced itch severity and overall urticaria activity over a 24-week period compared with placebo.^1,2 While second-generation H1-antihistamines remain the first-line defense for CSU and are effective in approximately half of all patients, many refractory cases previously required escalating doses or turning to omalizumab, which has served as the cornerstone of biologic therapy for patients aged 12 and older.^2,4,5

Dupilumab now provides a younger cohort with a mechanism of action that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13)—central drivers of the type 2 inflammation that fuels this disease.^1,2

Pharmacists must be acutely aware of the specific weight-based dosing and pharmacokinetic profile of dupilumab in this younger demographic. For children aged 2 to 5 years, the medication is administered every 4 weeks, with the dosage (200 mg or 300 mg) determined by whether the child weighs more or less than 15 kg. For children aged 6 to 11, the frequency and dose further vary based on weight brackets ranging from 15 kg to over 60 kg, often involving an initial loading dose.

Pharmacists should also note that while steady-state concentrations are typically reached by week 16 in adults, the clearance of dupilumab is notably increased in pediatric subjects aged 6 months to 5 years. Furthermore, the median time for the drug to become non-detectable in the plasma can be up to 2.5 times higher in young children compared with adults.²

Patient counseling and logistical management are essential roles for the pharmacist in ensuring treatment success.

Dupilumab must be stored in a refrigerator between 36°F and 46°F, though it can remain at room temperature for up to 14 days if necessary. Caregivers should be instructed to remove the syringe or pen from the refrigerator 45 minutes prior to injection and to never shake the medication.^2,6

Rotating injection sites between the thigh and abdomen are vital to minimize common injection site reactions, which remain the most frequently reported adverse effect. Additionally, pharmacists should monitor patients for signs of conjunctivitis, keratitis, or new-onset joint pain. They should also advise that all age-appropriate live vaccines be completed before starting therapy, as live virus vaccines are contraindicated during treatment.^1,2,6

Beyond CSU, dupilumab is already utilized for other type 2 inflammatory conditions such as atopic dermatitis and allergic fungal rhinosinusitis (AFRS), the latter of which was recently approved for patients as young as 6 years old.^1-3 This versatility highlights the drug’s role in breaking the cycle of recurrence for complex inflammatory disorders without the broad immunosuppression or systemic side effects associated with long-term corticosteroid use, such as osteoporosis or glucose intolerance.^2,3,6

As dupilumab becomes more prevalent in pediatric care, pharmacists will serve as pivotal figures in managing drug-drug interactions—particularly for patients on CYP450 substrates like warfarin—and providing the specialized education required for home administration by caregivers.^1,2

“Dupixent is the first biologic approved for patients as young as 2 years of age, offering a targeted approach that inhibits IL4 and IL13 signaling, 2 key and central drivers of the type 2 inflammation that contributes to this disease,” concluded Johnsen, according to the Sanofi release.¹ “Today’s approval underscores our ongoing commitment to advancing therapies for young patients with significant unmet needs.”

READ MORE: FDA Updates Resource Center

Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips, straight to your inbox.

REFERENCES

1. Sanofi and Regeneron’s Dupixent approved in the US as the first biologic medicine for young children with uncontrolled chronic spontaneous urticaria. News Release. Sanofi. April 22, 2026. Accessed April 27, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-22-21-30-00-3279472

2. Gade A, Ghani H, Patel P, et al. Dupilumab. [Updated 2024 Feb 28]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK585114/

3. Nowosielski B. FDA approves dupilumab for allergic fungal rhinosinusitis in patients 6 years and older. Drug Topics. February 24, 2026. Accessed April 27, 2026. https://www.drugtopics.com/view/fda-approves-dupilumab-for-allergic-fungal-rhinosinusitis-in-patients-6-years-and-older

4. Kocatürk E, Chu DK, Türk M, et al. Management of chronic spontaneous urticaria made practical: what every clinician should know. J Allergy Clin Immunol Pract. 2025;13(9):2252-2269. https://doi.org/10.1016/j.jaip.2025.07.021

5. Orzan OA, Popa LG, Mihai MM, et al. Current and future approaches in management of chronic spontaneous urticaria using anti-IgE antibodies. Medicina (Kaunas). 2022 Jun 17;58(6):816. doi: 10.3390/medicina58060816.

6. Thurrott S. Dupilumab (Dupixent): what you need to know. Banner Health. October 7, 2024. Accessed April 27, 2026. https://www.bannerhealth.com/healthcareblog/teach-me/dupilumab-dupixent-what-you-need-to-know