On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the IL-13 inhibitor tralokinumab (Adtralza) for the treatment of adults with moderate-to-severe atopic dermatitis (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 IL-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 last June. 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 (EASI-75). Safety of tralokinumab in these trials was comparable to 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 recently presented during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.
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, the US Food and Drug Administration accepted a Biologics License Application (BLA) for tralokinumab for the treatment of moderate-to-severe AD in adults. Data from the pivotal ECZTRA 1, 2 and ECZTRA 3 phase 3 studies were also submitted to the FDA alongside the BLA.
The FDA, under the Prescription Drug User Fee Act, expects to make a final decision in the second quarter of this year on whether to authorize tralokinumab in the US for the adult AD indication.