MHRA and EC approval for Adtralza in atopic dermatitis

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) have approved Adtralza (tralokinumab), from Danish drugmaker LEO Pharma, for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

The MHRA and EC approvals make tralokinumab the first and only approved biologic that specifically targets the interleukin (IL)-13 cytokine alone, a key driver of atopic dermatitis signs and symptoms. The European Medicines Agency’s Committee for Medicinal Products for Human US (CHMP) recommended the drug be approved in April this year.

Tralokinumab is the first high affinity, human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine in adult patients with uncontrolled moderate-to-severe atopic dermatitis. Tralokinumab will be available in a 150mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600mg followed by 300 mg every other week. Tralokinumab can be used with or without topical corticosteroids (TCS).