Privately-held Danish firm LEO Pharma has announced that both the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have approved an extension of the marketing authorization for Adtralza (tralokinumab) to include the treatment of adolescents aged 12 years and older.
Adtralza is a monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine in adult patients with uncontrolled moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
The product is approved for adults in the USA under the tradename Adbry.
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