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.
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 inflammatory skin disease.
The US 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 phase 3 studies were also submitted to the FDA alongside the BLA.
Source: Medscape