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CLAIM #37123 · Eli Lilly and Company (LLY) · 2026Q1 earnings call · Apr 30, 2026 · due Dec 31, 2026

We're pleased that our once every 8 weeks maintenance regimen is currently under FDA review, and we expect regulatory action later this year.

Dr. Dan Skovronsky · Chief Scientific and Product Officer

PENDING
graded after results covering Dec 31, 2026 are reported

How to check this claim

Look at: FDA regulatory action (approval decision) on the once-every-8-weeks maintenance dosing regimen supplemental application

It came true if: FDA issues a decision (approval, CRL, or other action) on this regimen by 2026-12-31

Where: Company press release / FDA action announcement (10-K or 8-K disclosure)

In context

Both NLRP3 inhibitors are now shown in the Lilly pipeline. We also announced a licensing agreement with CSL for clazakizumab for certain indications, and that molecule will be reflected in our pipeline chart once Lilly trials have begun. Moving to immunology. We reported 2 important data sets for [indiscernible] genotypes. First, in the ADO Phase IIIb OBI-label extension study, [indiscernible] delivered durable disease control for up to 4 years with 1 month [indiscernible] dosing. Nearly all patients achieved meaningful skin improvements, 75% achieved near complete skin clearance and 80% maintaining their results without the need for topical for corticosteroids. For people living with chronic relapsing diseases like atopic dermatitis sustained control delivered with [indiscernible] goal. We're pleased that our once every 8 weeks maintenance regimen is currently 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 l

Verify independently

SEC filings for LLY · Claim quote is verbatim from the 2026Q1 earnings call.