Is Ebglyss Approved for Pediatric Eczema?
No, Ebglyss (lebrikizumab-lbkz) is not approved for pediatric use in treating eczema (atopic dermatitis). The FDA approved it in September 2024 for adults and children 12 years and older weighing at least 40 kg (about 88 lbs) with moderate-to-severe atopic dermatitis that is not adequately controlled by topical prescription therapies or when those therapies are not advisable.[1] It has not been evaluated or approved for kids under 12, or for those 12+ who weigh less than 40 kg.
What Ages and Conditions Does Ebglyss Target?
Ebglyss is indicated for moderate-to-severe atopic dermatitis in patients 12 years and older meeting the weight threshold. Administered as a subcutaneous injection every two weeks after initial doses, it targets IL-13, a key cytokine in eczema inflammation. Safety and efficacy data come from three phase 3 trials (ADvocate1, ADvocate2, ADjoin) involving over 850 adults and 231 adolescents aged 12-17.[1][2] No data supports use in younger children.
How Does This Compare to Other Eczema Drugs for Kids?
Dupixent (dupilumab), a rival IL-4/IL-13 inhibitor, has broader pediatric approval: ages 6 months and up for severe cases, down to 6 years for moderate-to-severe.[3] Ebglyss's label excludes under-12s due to lack of trials; ongoing studies may expand access. For kids under 12, options remain limited to topicals like corticosteroids or calcineurin inhibitors, or off-label use where approved drugs fit.
What Pediatric Trials Are Underway for Ebglyss?
Eli Lilly (Ebglyss's developer) is running pediatric trials. ADvocate2Kid (NCT05231614) tests it in ages 6 months to 11 years with moderate-to-severe atopic dermatitis; topline results expected in 2025.[4] Another (NCT06038249) evaluates pharmacokinetics in 2- to 17-year-olds. Approval for younger kids would require positive data and FDA review, potentially by 2026.
When Could Ebglyss Expand to Younger Kids?
No timeline is set; it depends on trial outcomes. Dupixent took about two years from adult approval (2017) to pediatric expansion (2019). Eli Lilly has not filed supplemental applications for under-12s yet. Patent protection lasts until at least 2037 in the US.[5]
[1]: FDA Label for Ebglyss
[2]: NEJM: Lebrikizumab Phase 3 Trials
[3]: FDA Label for Dupixent
[4]: ClinicalTrials.gov: ADvocate2Kid
[5]: DrugPatentWatch.com: Ebglyss Patents