Lebrikizumab for Atopic Dermatitis Resubmitted for FDA Approval After Previous Rejection

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It was announced by Eli Lilly and Company that the pharmaceutical company had resubmitted lebrikizumab to the US Food and Drug Administration (FDA) for treatment of adult and adolescent patients with atopic dermatitis.¹

The resubmission follows the October 2023 decision by FDA officials to issue a complete response letter (CRL) to lebrikizumab’s biologic license application (BLA) for the treatment of the skin disease. At the time, those with the FDA had highlighted that they did not have concerns as far as the drug’s clinical data package, safety, or labeling.²

The CRL included an acknowledgement of findings uncovered by the FDA during a multi-sponsor inspection of the drug done by a third-party contract manufacturing group. The group that had uncovered these findings was reportedly responsible for the production of the monoclonal antibody drug substance for lebrikizumab.

Prior to the CRL in 2023, Lilly had submitted to the FDA the data drawn from the ADvocate 1, ADvocate 2, and ADhere trials. The studies had involved a group of more than 1,000 adult and adolescent participants aged 12 years and older with moderate-to-severe eczema.

In November 2023, an approval was granted to lebrikizumab in the European Union for the treatment of adults and adolescents in this same age range with moderate-to-severe atopic dermatitis and a weight of 40 kg or more. These patients would also have to be candidates for systemic treatment.³

The eczema drug was also given approval for this indication in the UK by December 2023 and in Japan by January 2024.³ Following Lilly’s new resubmission for lebrikizumab in the US, the company will await a new regulatory decision prior to the drug’s potential approval in atopic dermatitis patients.

References

1. ^{Lilly Reports First-Quarter 2024 Financial Results and Raises Full-Year Revenue Guidance by $2 Billion, Highlights Pipeline Momentum. Lilly. April 30, 2024. https://investor.lilly.com/news-releases/news-release-details/lilly-reports-first-quarter-2024-financial-results-and-raises. Date accessed: April 30, 2024.}
2. ^{Smith T. FDA Issues Complete Response Letter for Lebrikizumab Treatment of Eczema. HCPLive. October 2, 2023. https://www.hcplive.com/view/fda-issues-complete-response-letter-lebrikizumab-treatment-eczema. Date accessed: April 30, 2024.}
3. ^{Keam SJ. Lebrikizumab: First Approval. Drugs. 2024 Mar;84(3):347-353. doi: 10.1007/s40265-024-02000-z. PMID: 38388870.}