CLAIM #36546 · Eli Lilly and Company (LLY) · 2022Q1 earnings call · Apr 28, 2022 · due Jun 30, 2022
“We are also excited to announce that we have submitted to the FDA and expect submissions in Europe and Japan in Q2.”
Dr. Dan Skovronsky · CSO
In context
“ve advanced our long-acting Amylin receptor agonist to Phase I development in obesity. Shifting to immunology, we presented mirikizumab induction data from LUCENT-1 at the Europeans Crohn’s and Colitis Virtual Congress, demonstrating superiority over placebo for the primary and all key secondary endpoints. These data show patients with moderately to severely active ulcerative colitis achieved statistically superior rates of clinical remission compared to patients taking placebo, with nearly two-thirds of patients responding to mirikizumab. The results indicated improved symptom relief, including decreased bowel urgency and resolution or near resolution of inflammation. Building upon the positive outcomes from LUCENT-1, we look forward to sharing maintenance data from LUCENT-2 later in Q2. We are also excited to announce that we have submitted to the FDA and expect submissions in Europe and Japan in Q2. Mirikizumab has the potential to be the first-in-class L-23p19 inhibitor treatment for people with ulcerative colitis. Last month at the American Academy of Dermatology Annual Meeting, we shared lebrikizumab monotherapy data showing more than 50% of patients with moderate to severe atopic dermatitis experienced at least 75% reduction in disease severity at 16 weeks. Additionally, at the revolutionizing atopic dermatitis conference, we shared data showing 70% of patients receiving lebrikizumab combined with topical corticosteroids achieved at least 75% improvement in overall disease severity. We believe these data could help establish a competitive profile for lebrikizumab and we are looking forward to further data from our maintenance studies in the first half of this year to provide insi”
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SEC filings for LLY ↗ · Claim quote is verbatim from the 2022Q1 earnings call.