FDA Issues Complete Response Letter for Lebrikizumab

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Eli Lilly announced today that the FDA issued a complete response letter (CRL) for the biologic license application (BLA) of lebrikizumab (Ebglyss) for the treatment of moderate to severe atopic dermatitis. The FDA’s letter cited 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.¹

"We are confident in lebrikizumab's potential to help people living with eczema and in the clinical data that supports our submission package for the medicine," said Patrik Jonsson, executive vice president of Eli Lilly, president of Lilly Immunology and Lilly USA, and the chief customer officer, in the news release. "We will continue to work closely with the third-party manufacturer and the FDA to address the feedback in order to make lebrikizumab available to patients."

Eli Lilly’s BLA for lebrikizumab 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.

Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency released a positive opinion recommending marketing authorization of lebrikizumab in Europe.²

“The positive CHMP recommendation for Ebglyss in moderate to severe AD represents a significant milestone in bringing a next-generation biologic therapy to people living with atopic dermatitis, providing a much-needed additional treatment option,” said Karl Ziegelbauer, chief scientific officer at Almirall, Eli Lilly's partner company for lebrikizumab, in the earlier news release. “We are confident that Ebglyss, thanks to its selective mechanism of action, proven long-term efficacy and patient friendly monthly maintenance dosing, has the potential to become a first-line treatment for moderate-to-severe atopic dermatitis.”

References

1. US Food and Drug Administration issues complete response letter for lebrikizumab based on inspection findings at third-party manufacturer. Eli Lilly. News release. October 2, 2023. Accessed October 2, 2023. https://investor.lilly.com/news-releases/news-release-details/us-food-and-drug-administration-issues-complete-response-2
2. Ebglyss (lebrikizumab) receives positive CHMP opinion for moderate-to-severe atopic dermatitis. Businesswire. News release. September 15, 2023. Accessed October 2, 2023. https://www.businesswire.com/news/home/20230915131004/en/EBGLYSS%C2%AE-lebrikizumab-Receives-Positive-CHMP-Opinion-for-Moderate-to-severe-Atopic-Dermatitis