BLA resubmitted for lebrikizumab to treat AD patients 12 years and up
The resubmission was announced in a first quarter, 2024 earnings news release from Lilly, which expects "regulatory action in the second half of 2024."
BLA resubmitted for lebrikizumab to treat AD patients 12 years and up | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.
Following the issuance of a Complete Response Letter (CRL) for lebrikizumab in October 2023, Eli Lilly and Company has resubmitted a Biologic License Application (BLA) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older.1,2
The resubmission was announced in a first quarter, 2024 earnings news release from Lilly, which expects "regulatory action in the second half of 2024." The BLA is for the aforementioned patient population who are unable to control symptoms with topical medicines or other systemic treatments.1,2
After initial submission, the FDA issued a CRL for lebrikizumab on October 2, 2023, citing "findings that arose during a multi-sponsor inspection of a third-party, contract manufacturing organization that included the monoclonal antibody drug substance for Lilly's lebrikizumab," the company stated at the time, noting no concerns about the clinical data package associated with the submission.2
The BLA was submitted based on data from the phase 3 ADvocate 1 (NCT04146363) and ADvocate 2 (NCT04178967) studies that took place over 52 weeks and featured over 1000 adults and adolescents.2,3
In the trials, deep responses were defined as total skin clearance (Investigator’s Global Assessment [IGA], Eczema Area and Severity Index [EASI] 100, and itch relief [NRS 0,1]). Deep responses were achieved in 20% and 31% of patients in ADvocate 1 and ADvocate 2, respectively, by week 16 and were maintained or increased through week 52.3
According to the earnings report, results from a phase 3 study of lebrikizumab, designed specifically for people with skin of color and moderate-to-severe AD, were reported. Lilly stated participants "showed improvement in skin clearance and itch relief."1
"Lilly's first quarter performance reflects solid year-over-year revenue growth with strong sales of Mounjaro and Zepbound," said David A. Ricks, chair and CEO, Lilly.
"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 Ricks.
References:
1. Lilly reports first-quarter 2024 financial results and raises full-year revenue guidance by $2 billion, highlights pipeline momentum. Eli Lilly and Company. Press release. 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. US Food and Drug Administration issues Complete Response Letter for Lebrikizumab based on inspection findings at third-party manufacturer. 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
3. Fitch, J. Lebrikizumab improves AD symptoms for adolescents inadequately controlled with cyclosporine. Contemporary Pediatrics. October 17, 2023. Accessed April 30, 2024. https://www.contemporarypediatrics.com/view/lebrikizumab-improves-ad-symptoms-for-adolescents-inadequately-controlled-with-cyclosporine
