FDA rejects Lilly’s eczema treatment over third-party manufacturing issues
Published: Oct 02, 2023
By Tristan Manalac
In its Complete Response Letter, the regulator pointed to “findings” during a “multi-sponsor inspection of a third-party, contract manufacturing organization,” which included issues related to lebrikizumab. However, the FDA did not identify concerns regarding Lilly’s clinical data package, lebrikizumab’s safety profile or the proposed label for the product, according to the company.
Despite the FDA’s rejection, the company remains “confident” in lebrikizumab and its potential to “help people living with eczema,” Patrik Jonsson, executive vice president of Lilly Immunology and Lilly USA, said in a statement.
Lilly will work with both the FDA and the third-party service provider to address the manufacturing issues and “make lebrikizumab available to patients,” Jonsson said.
The FDA’s rejection does not affect any of Lilly’s other pipeline or marketed products, according to the company’s announcement on Monday.
Lilly is proposing lebrikizumab as a treatment for moderate-to-severe atopic dermatitis (AD). The biologic candidate works by binding to the IL-13 cytokine, a key immunoregulatory player involved in AD pathology that drives itching, skin thickening and skin barrier dysfunction. Lebrikizumab previously won the FDA’s Fast Track designation.
The company announced that it submitted a Biologics License Application for lebrikizumab during its third-quarter 2022 earnings report, filed in November of that year. The application included data from over 1,000 adult and adolescent patients across the ADvocate 1, AdDocate 2 and ADhere studies.
Lilly in April 2022 posted data from the ADhere study, showing that lebrikizumab combined with topical corticosteroids outperformed placebo at inducing clear skin or almost clear skin in patients with moderate-to-severe disease over 16 weeks of treatment.
In June 2022, Lilly announced promising topline data from ADvocate1 and ADvocate 2, which showed that around eight out of 10 patients with moderate-to-severe AD maintained skin clearance over 52 weeks.
The company in September 2022 also released new data from these studies, demonstrating that patients who responded to treatment saw durable effects at one year including skin clearance, itch and disease extent and severity.
Lebrikizumab is one of four investigational molecules that Lilly was expecting to launch this year, as announced during the 41st J.P. Morgan Healthcare Conference in January 2023. The other candidates include donanemab—still being reviewed in Alzheimer’s disease—and pirtobrutinib, now marketed as Jaypirca in relapsed or refractory mantle cell lymphoma.
The final investigational asset, mirikizumab, was rejected by the FDA in April 2023 for ulcerative colitis due to manufacturing issues.