FDA Issues Complete Response Letter for Lebrikizumab Treatment of Eczema

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This news was announced following new findings by the FDA due to a recent inspection, though no concerns were listed regarding clinical data, labeling, or safety.

An announcement was made by Eli Lilly and Company that the US Food and Drug Administration (FDA) had issued a new complete response letter (CRL) to lebrikizumab’s biologic license application (BLA) for the treatment of atopic dermatitis.1

Notably, the new CRL touched upon findings which the FDA had uncovered at the time of a multi-sponsor inspection of a third-party contract manufacturing organization.

This organization was known to be responsible for producing the monoclonal antibody drug substance for Lilly's lebrikizumab.

"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," Patrik Jonsson, president of Lilly Immunology and Lilly USA and the company’s chief customer officer, said in a statement.

FDA officials did note that the newly-issued CRL does not touch upon any concerns by the agency regarding the safety, clinical data package, or labeling of the eczema drug.

Lilly had provided the agency with data from the ADvocate 1, ADvocate 2, and ADhere trials, which had involved a participant group of more than 1,000 adults and adolescents in the age range of 12 and above and had moderate-to-severe eczema.2,3

The subjects included in the ADvocate and ADHere studies had not found relief from topical medications or alternative systemic treatments prior to lebrikizumab.

The agency’s decision to issue the CRL for the drug does not impact any of the other products in Lilly's portfolio, whether they are already on the market or in development.

"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,” Jonsson noted in his statement.

References

  1. U.S. Food and Drug Administration Issues Complete Response Letter for Lebrikizumab Based on Inspection Findings at Third-Party Manufacturer. PR Newswire. October 2, 2023. Date accessed: October 2, 2023. https://www.prnewswire.com/news-releases/us-food-and-drug-administration-issues-complete-response-letter-for-lebrikizumab-based-on-inspection-findings-at-third-party-manufacturer-301943925.html.
  2. Butera A. Lebrikizumab Effective in Patients with Moderate-to-Severe Atopic Dermatitis. HCPLive. August 16, 2021. Date accessed: October 2, 2023. https://www.hcplive.com/view/lebrikizumab-effective-patients-moderate-severe-atopic-dermatitis.
  3. Smith T. Lebrikizumab Maintained Efficacy, Safety Up to a Year for Atopic Dermatitis With or Without Topical Corticosteroids. HCPLive. July 20, 2023. Data accessed: October 2, 2023. https://www.hcplive.com/view/lebrikizumab-maintained-efficacy-safety-up-to-a-year-for-atopic-dermatitis-with-or-without-topical-corticosteroids/.
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