On April 23, the (AD) who are eligible for systemic therapy.
The new opinion represents the final stages before the European Commission decides whether tralokinumab will be authorized for use throughout the European Union. The final decision should be made in the next few months.
If ultimately authorized, tralokinumab would become the first approved fully human monoclonal antibody targeting the interleukin-13 cytokine, a key factor that drives the signs and symptoms of AD. Tralokinumab has previously shown to target IL-13 with high affinity and subsequently improve symptoms associated with the inflammatory skin disease.
The EMA accepted the marketing application for tralokinumab back in June 2020. Submitted alongside the marketing application were data from the ECZTRA 1, 2, and 3 pivotal randomized, placebo-controlled trials.
In the ECZTRA trials, treatment with tralokinumab, either alone or with topical corticosteroids, was associated with significant improvements in the Investigator Global Assessment score of clear or almost clear skin and at least a 75% improvement in the Eczema Area and Severity Index score. Safety of tralokinumab in these trials was comparable with that reported with placebo.
Interim data from the open-label extension trial, ECZTEND, also showed that treatment with tralokinumab was associated with durable efficacy in adult patients with moderate to severe AD. Patients in this study were previously enrolled in the ECZTRA 1 and 2 parent trials and had received the IL-13 inhibitor for up to 2 years. Data from this trial were presented at the 2021 American Academy of Dermatology Virtual Meeting Experience.
Pending the European Commission’s final decision, the Marketing Authorization Application for use of tralokinumab in adults with moderate to severe AD will be valid in across all European Union member states in addition to Iceland, Norway, and Liechtenstein. Other regulatory filings for the drug are currently underway with health authorities from various countries worldwide.
Back in July 2020, the Food and Drug Administration accepted a Biologics License Application for tralokinumab for the treatment of moderate to severe AD in adults. Data from the pivotal ECZTRA 1, 2, and ECZTRA 3 trials were submitted to the FDA.
The FDA expects to make a final decision in the second quarter of this year on whether to approve tralokinumab in the United States for the adult AD indication.
A version of this article first appeared on Medscape.com.