CLAIM #37124 · Eli Lilly and Company (LLY) · 2026Q1 earnings call · Apr 30, 2026 · due Dec 31, 2026
“We plan to submit these data to regulators later this year for potential labels.”
Dr. Dan Skovronsky · Chief Scientific and Product Officer
How to check this claim
Look at: Regulatory submission status for pediatric atopic dermatitis label expansion (based on the Phase III trial in children as young as 6 months old)
It came true if: Company or regulator confirms submission was made to at least one regulator (e.g., FDA or EMA) by 2026-12-31
Where: Company press releases, 10-K/10-Q filings, or management commentary on quarterly earnings calls
In context
“rrently under FDA review, and we expect regulatory action later this year. If approved, less frequent dosing may be a more convenient option to improve the patient experience and further differentiate uplift from competitors. The second readout was the Phase III adorable line trial. [indiscernible] delivered positive outcomes for children as young as 6 months old with moderate to severe atopic dermatitis. As shown on Slide 16, 63% of children treated with [indiscernible] achieved significant skin improvement as measured by EASI-75. In addition, 44% achieved clear or almost clear skin as endured by IGA 0 score. This makes edges the first and only selective IL-13 inhibitor with positive Phase III data in this age group where there are fewer approved medicines than in adolescents and adults. We plan to submit these data to regulators later this year for potential labels. Also in immunology, reported positive top line results from together PSO the Phase IIIb study of ixekizumab plus tirzepatide in adults with psoriasis and obesity. And together, PSO, 27% of participants on tirzepatide plus ixekizumab achieved the co-primary endpoint of total skin clearance and 10% or more weight loss compared to less than 6% of patients on [indiscernible] alone. These results are the second successful trial, highlighting the benefits of treating psoriatic disease and obesity with concomitant ixekizumab and tirzepatide therapy. This result provides further evidence that incretins they have a broader role in treating immunological diseases. We have additional ongoing Phase IIb combination trials in immunology studying mirikizumab plus tirzepatide in Crohn's disease and ulcer”
Verify independently
SEC filings for LLY ↗ · Claim quote is verbatim from the 2026Q1 earnings call.