On October 2, Eli Lilly and Company announced that it had received a communication from the FDALebrikizumabUsed for treatmentModerate to Severe Atopic Dermatitis (AD)TheBiologics License Application (BLA)The Complete Response Letter (CRL) issued. The press release noted that the FDA's decision to refuse approval in the CRL was mainly due to findings during the inspection.Third-Party Contract Manufacturing OrganizationsQuestion,AndTo LebrikizumabClinical DataAccording to the package, safety, and instructionsNo indicationAnyConcern.Lebrikizumab is a novel anti-IL-13 monoclonal antibody that binds soluble IL-13 with high affinity, blocking IL-13-mediated signaling pathways. Lebrikizumab is characterized by high bioavailability and a long half-life.Eli Lilly and Company has previously submitted to the FDAADvocate 1, ADvocate 2 andADHERE study data. These three studies collectively enrolled over 1000 patients with moderate to severe AD.Adults and adolescents (12Years and above)Patients, these patients have skin symptomsCannot be controlled by topical medications or other systemic treatments.ADvocate 1 and ADvocate 2 are two 52-week, randomized, double-blind, placebo-controlled, parallel-group Phase III studies designed to evaluate the efficacy of Lebrikizumab monotherapy in adult and adolescent patients (12-18 years old, weight ≥40kg) with moderate to severe AD. The primary endpoints are the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin) with at least a 2-point improvement from baseline andProportion of patients with at least 75% improvement in Eczema Area and Severity Index (EASI 75).The research results show that,At 16 weeks of treatment, LEbrikizumab GroupIGA 0/1 score decreased by at least 2 from baselinePoints,More than half of patients with moderate to severe AD achieved EASI 75, the trial met its primary endpoint;At the same time,Compared with placebo, LebrIkizumab can significantly improveThe interference of itching on patients' sleep and quality of life reached the key secondary endpoint.In terms of safety, the incidence of adverse events (AEs) and serious AEs in the Lebrikizumab group was consistent with the Phase II study of Lebrikizumab for the treatment of AD. The most common AEs included conjunctivitis, nasopharyngitis, and headache. The rate of discontinuation due to AEs in the Lebrikizumab group (1.4%) was similar to that in the placebo group (1.7%).Phase III Study of Lebrikizumab in Combination with Topical Corticosteroids (TCS) for the Treatment of AD PatientsADHERE study also met the primary endpoint。In addition, the study also achieved all key secondary endpoints.Key endpoints, including improvement in skin symptoms, relief of itching, etc.The safety data were consistent with the results of the two previously published single-agent trials.Eli LillySenior Vice President, Eli Lilly Immunology Department andPresident of Eli Lilly U.S. and Chief Customer OfficerPatrik Jonsson stated"We are confident in the therapeutic potential and clinical data of Lebrikizumab for patients with atopic dermatitis. Moving forward, we will continue to work closely with third-party manufacturers and the FDA to address feedback and ensure Lebrikizumab is available for patients."
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