Eli Lilly Resubmits BLA for Lebrikizumab for the Treatment of Moderate to Severe AD

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Eli Lilly recently announced in its first-quarter financial results meeting of 2024 that it has resubmitted its biologics license application (BLA) for lebrikizumab (Ebglyss) for the treatment of adults and adolescents aged 12 years and older with moderate to severe atopic dermatitis that is inadequately controlled with topical or systemic treatments. A decision from the US Food and Drug Administration (FDA) is expected in the second half of 2024.¹

Additionally, Eli Lilly provided updates that results from a phase 3 study of lebrikizumab that was specifically designed to assess moderate to severe atopic dermatitis in patients with skin of color showed improvement in skin clearance and itch.

"Our progress in addressing some of the world's most significant health care challenges has resulted in increased demand for our medicines. As we continue to make pipeline investments that position us for future growth, we are rapidly expanding manufacturing capacity to make our incretin medicines available to more patients,” said David A. Ricks, Eli Lilly's chair and chief executive officer, in the news release.

Most recently, lebrikizumab was approved by the European Commission in November 2023 for the treatment of atopic dermatitis. Germany became the first country where lebrikizumab was available as a prescription. Almirall has the licensed rights to develop and commercialize lebrikizumab in Europe, while Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and the rest of the world.²

The FDA issued a complete response letter (CLR) to Eli Lilly in October 2023 for its BLA of lebrikizumab for the treatment of atopic dermatitis due to findings from a multi-sponsor inspection of a third-party, contract manufacturing organization that included the monoclonal antibody drug substance for lebrikizumab. No concerns were cited about the clinical data package, safety, or label of lebrikizumab.³

The submission of lebrikizumab’s BLA was based on data from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adult and adolescent (ages 12 and older) patients with moderate to severe atopic dermatitis who were unable to control their symptoms with topical medicines or other systemic treatments.³

References

1. Lilly reports first-quarter 2024 financial results and raises full-year revenue guidance by $2 billion, highlights pipeline momentum. News release. Eli Lilly. April 30, 2024. Accessed April 30, 2024. https://investor.lilly.com/news-releases/news-release-details/lilly-reports-first-quarter-2024-financial-results-and-raises
2. Almirall receives European Commission approval of EBGLYSS (lebrikizumab) for moderate-to-severe atopic dermatitis. News release. Almirall. November 17, 2023. Accessed April 30, 2024. https://www.almirall.com/newsroom/news/almirall-receives-european-commission-approval-of-ebglyss-lebrikizumab-for-moderate-to-severe-atopic-dermatitis
3. US Food and Drug Administration issues complete response letter for lebrikizumab based on inspection findings at third-party manufacturer. News release. Eli Lilly. October 2, 2023. Accessed April 30, 2024. https://investor.lilly.com/news-releases/news-release-details/us-food-and-drug-administration-issues-complete-response-2