MHRA approves LEO Pharma’s Adtralza for adolescent patients with atopic dermatitis

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved to the extend the terms of the marketing authorisation for LEO Pharma’s Adtralza (tralokinumab) to include the treatment of adolescent patients, aged 12 years and older, with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy.

The changes were also approved by the European Commission (EC) in October this year, a decision applicable to all EU member states, including Ireland and Northern Ireland, as well as Iceland, Norway and Liechtenstein.

Adtralza is a high affinity, human monoclonal antibody developed to specifically bind to and inhibit the interleukin (IL)-13 cytokine, which plays an important role in the immune and inflammatory processes underlying AD symptoms.

The company’s application was supported by results from the ECZTRA 6 clinical trial evaluating the efficacy, safety and tolerability of Adtralza (150mg or 300mg) monotherapy compared to placebo in 301 AD patients aged 12 to 17 years, with 289 – 195 Adtralza patients and 94 placebo patients – in the full analysis set.

The recommended dose for adolescent patients is an initial dose of 600mg followed by 300mg administered every other week, which is the same as for adult patients.

AD is a chronic, inflammatory skin disease characterised by intense itch and eczematous lesions, and a result of skin barrier dysfunction and immune dysregulation. Approximately 6% of adolescents aged 12 to 17 years have AD in the UK.

Research has shown that moderate-to-severe AD can take a physical, psychosocial and emotional toll on adolescent patients, and there is a significant unmet need for well-tolerated and effective treatments.

“AD is an underestimated condition that has a significant impact on a young person’s quality of life. The extended approval of [Adtralza] for the treatment of adolescents with AD is an important development, giving dermatologists more treatment options for this group of patients,” said Dr James Halpern, consultant dermatologist for Dermatology at Walsall Healthcare NHS Trust.

Also commenting on the approval, Sarah Kleinpeter, vice president and general manager of UK and Ireland at LEO Pharma, said: “We are pleased that adolescents between 12 to 17 years-of-age living with AD will now have more treatment options available to them. LEO Pharma is committed to working with regulatory authorities to make tralokinumab available to all patients who need it.”

To date, tralokinumab is also approved for the treatment of adults with moderate-to-severe atopic dermatitis in Canada, the UAE and Switzerland. It is also approved for adults in the US under the trade name Adbry.