LEO Pharma has received approval from Health Canada for Adtralza (tralokinumab) to treat moderate-to-severe atopic dermatitis (AD).
Adtralza has received approval to treat AD in people aged 12 to 17 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The human, monoclonal antibody, Adtralza has been developed for specifically targeting the interleukin (IL)-13 cytokine, which plays an important role in driving the signs and symptoms of AD.
It is claimed to be the first and only approved treatment that specifically binds to and inhibits the IL-13 cytokine.
LEO Pharma Canada president and CEO Jill Archibald said: “We are pleased to offer Canadian adolescents living with moderate-to-severe AD with another option to help manage this challenging and complex condition.
“The approval of Adtralza for this age group is another step forward in LEO Pharma’s ongoing commitment to improving research, standard of care, and support for people living with skin diseases.”
The regulatory approval is based on the data obtained from the Phase III ECZTRA 6 trial, which assessed Adtralza (150mg/300mg) monotherapy’s safety and efficacy against placebo in 289 AD patients.
The findings showed that Adtralza met the trial’s primary endpoints at week 16 as measured by an IGA score of clear or almost clear skin, and/or atleast 75% improvement in EASI score.
The recommended dosage is 600mg initial loading dose, followed by 300mg, to be given every other week.
Eczema Society Canada executive director Amanda Cresswell-Melville said: “Living with atopic dermatitis can be debilitating and can have a profound impact on the mental and physical health of sufferers.
“New treatment options can bring hope to patients and their families.”