TORONTO, Feb. 8, 2023 – LEO Pharma Inc. today announced the Health Canada approval of Adtralza® (tralokinumab) for adolescent patients aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adtralza® can be used with or without topical corticosteroids (TCS).1 Adtralza® is the first and only approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, one of the drivers of AD signs and symptoms.1,2,3
Health Canada’s approval is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adtralza® (150 mg or 300 mg) monotherapy compared to placebo in 289 adolescents with moderate-to-severe AD who had a previous inadequate response to topical medication.4 The approved dose for adolescent patients is an initial loading dose of 600 mg followed by 300 mg administered every other week, which is the same dosing as for adult patients.1 A dosage of 300 mg every four weeks may be considered for some patients who achieve clear or almost clear skin after 16 weeks of treatment.1
«AD is a complex disease, and it’s common for adolescents living with moderate-to-severe AD to cycle through a number of treatment options,» said Dr. Chih-ho Hong, M.D., board certified dermatologist working in Greater Vancouver, BC, and national coordinating investigator for ECZTRA 6 trial in Canada. «For years, there have been limited treatment options for adolescents living with moderate-to-severe AD, so the approval of tralokinumab in this age group means that Canadian patients now have another option in their toolbox to help in the management of this chronic disease.»
In the ECZTRA 6 trial, Adtralza® met the primary endpoints at Week 16 as measured by an IGA score of clear or almost clear skin (IGA 0/1) and/or at least a 75% improvement in the EASI score (EASI-75).4 Adtralza® also met the secondary endpoint of reduction in itch as measured by the proportion of subjects with ≥4-point improvement in Adolescent Worst Pruritus NRS from baseline.4
«Living with atopic dermatitis can be debilitating and can have a profound impact on the mental and physical health of sufferers,» said Amanda Cresswell-Melville, Executive Director, Eczema Society of Canada. «New treatment options can bring hope to patients and their families.»
«We are pleased to offer Canadian adolescents living with moderate-to-severe AD with another option to help manage this challenging and complex condition,» said Jill Archibald, President and CEO, LEO Pharma Inc., Canada. «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.»
About Adtralza® (tralokinumab)1,2
Adtralza® (tralokinumab) is a human, monoclonal antibody developed to specifically target the IL-13 cytokine, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms. Adtralza® specifically binds to the IL-13 cytokine with high affinity, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).
For more information, please refer to the product monograph for Adtralza® in Canada located here.
About Atopic Dermatitis/Eczema5
Eczema is a chronic inflammatory skin condition, characterized by dry skin, with patches that are red and intensely itchy. These patches of eczema may ooze, become scaly, crusted, or hardened. Symptoms can range from mild to severe and the condition can negatively impact quality of life. Eczema can occur anywhere on the skin and is commonly found on the flexors (bends of the arms and backs of the knees). There are many types of eczema, with the most common one being atopic dermatitis. Atopy refers to a hereditary tendency toward eczema, asthma, and allergic rhinitis (hay fever). People with eczema may suffer with one of the other atopic diseases.
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,600 people, serving millions of patients across the world.
For more information, please visit www.leo-pharma.ca
Adtralza® is a registered trademark of LEO Pharma A/S under license and distributed by LEO Pharma Inc. Canada
| 1 Adtralza® (tralokinumab) Canada Product Monograph. February 2023. Available at: https://www.leo-pharma.ca/Admin/Public/DWSDownload.aspx?File=%2fFiles%2fFiler%2fLEO_local_downloads%2fLEO-Pharma.ca%2fconsumer_information%2fAdtralza+PM+-+EN+-03+FEB+2023.pdf |
| 2 Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62. |
| 3 Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017; 429:208-19. |
| 4 Paller A. Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial. Fall Clinical. Oct. 21-24, 2021. Poster Presentation. |
| 5 Eczema Society of Canada. About Eczema. Available at: https://eczemahelp.ca/about-eczema/ |
SOURCE LEO Pharma Canada