CLAIM #36841 · Eli Lilly and Company (LLY) · 2024Q1 earnings call · Apr 30, 2024 · due Dec 31, 2024
“We expect regulatory action in the second half of this year.”
Dr. Dan Skovronsky · Chief Scientific Officer
In context
“patients and look forward to addressing the FDA's questions in this form. Additionally, we made the decision to discontinue investigation of GBA1, our gene therapy assets in Gaucher disease type 2. Phase II studies in Parkinson's disease and Gaucher disease type 1 are still underway and have not been impacted by this decision. Finally, in immunology, we've submitted mirikizumab to the FDA and EMA for approval for use in adults with moderately to severely active Crohn's disease. In the U.S., we've resubmitted lebrikizumab's application to the FDA for moderate to severe atopic dermatitis. This is following a complete response letter based on inspection findings of the third-party manufacturer. As a reminder, the letter stated no concerns with the clinical data package safety or label. We expect regulatory action in the second half of this year. We're also announcing that in the coming months, we'll be initiating Phase III studies evaluating lebrikizumab in two new indications: chronic rhinosinusitis with nasal polyposis and allergic rhinitis due to perennial allergens. Lebrikizumab will be the first biologic to be evaluated in Phase III for allergic rhinitis. We're optimistic about the potential of lebrikizumab to be an important treatment option in these patient populations as well as in atopic dermatitis. In earlier-stage immunology development, we've advanced our CD19 antibody into Phase II for multiple sclerosis. I'll now turn the call back to Dave for closing remarks. David Ricks: Okay. Thanks, Dan. Before we go to Q&A, let me briefly sum up the progress in our first quarter. Strong revenue growth in Q1 was driven by”
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SEC filings for LLY ↗ · Claim quote is verbatim from the 2024Q1 earnings call.