BRIEF—Danish regulator backs LEO Pharma's Adtralza

28 April 2023

The Danish Medicines Council (DMC) has published a new treatment guideline for atopic dermatitis (AD).

The DMC recommends Adtralza (tralokinumab), from privately-owned dermatology specialist LEO Pharma, as a first-line treatment option for moderate-to-severe AD patients aged 12 years and older with inefficient effect from conventional systemic treatments.1

The assessment of Adtralza is based on data from the pivotal Phase III trials ECZTRA 1, 2, and ECZTRA 3 as well as the ECZTRA 6 (adolescent trial) and the ECZTRA 7 trial.

The treatment guideline recommends biologics, including Adtralza, as the first-line treatment for patients with inefficient effect from conventional systemic treatments.

With the treatment guideline published, Adtralza will now be available as a standard treatment in Denmark for eligible patients.

The updated treatment guideline from the Danish Medicines Council, marks the 15th market where Adtralza is available for treatment of patients with moderate-to-severe atopic dermatitis.

Sales of Adtralza are predicted to reach $1.6 billion by 2027.

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