MHRA approves LEO Pharma's Adtralza pre-filled pen

20 September 2023

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Adtralza (tralokinumab) in a new pre-filled pen, developed by privately-held Danish dermatology specialist LEO Pharma.

Tralokinumab is indicated for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy. It is a high-affinity fully human monoclonal antibody developed to specifically bind to and inhibit the interleukin (IL)-13 cytokine, which has previously been available in a 150mg in 1ml pre-filled syringe.

This approval follows the European Commission (EU) decision on September 1, 2023. Sales of Adtralza are predicted to reach $1.6 billion by 2027.

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