Health Canada approves ADTRALZA® (tralokinumab) as a treatment for adults with moderate-to-severe atopic dermatitis

• Adtralza^® (tralokinumab) is a Health Canada approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms^1,2,3
• In three pivotal Phase 3 studies, Adtralza demonstrated significant improvements in signs and symptoms of moderate-to-severe atopic dermatitis ^1,4,5

THORNHILL, ON, Oct. 18, 2021 /CNW/ - LEO Pharma Inc. announced today the Health Canada approval of Adtralza^® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults aged 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Adtralza is a high affinity, human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine in adult patients with uncontrolled moderate-to-severe AD.^1,2,3  Adtralza will be available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week. Adtralza can be used with or without topical corticosteroids (TCS).¹

"Living with moderate-to-severe atopic dermatitis means living with an inflammatory skin condition that includes significant disease activity with a rash on swollen or fissured skin and unrelenting itch and skin pain leading to major impacts across Quality-of-Life parameters including sleep and mental well-being," said Dr. Melinda Gooderham, Dermatologist and Medical Director at the SKIN Centre for Dermatology. "Adtralza represents a new and important tool that can be used to combat this condition by blocking the activity of IL-13, a key protein in the body's inflammatory process, thereby reducing the inflammation and symptoms associated with advanced AD." 

The Health Canada approval of Adtralza is based on safety and efficacy results from the randomized, double-blind, placebo-controlled Phase 3 studies (ECZTRA 1, 2 and ECZTRA 3) which included 1,976 adult patients (including over 300 Canadians) with moderate-to-severe AD who had a previous inadequate response to topical medication.¹

In all three pivotal trials, Adtralza 300 mg every other week (plus TCS as needed in ECZTRA 3) met the primary endpoints at Week 16 as measured by an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75).¹  Secondary endpoints, including  ≥4-point reduction in the Worst Daily Pruritus (itching) Numeric Rating Scale (weekly average) at Week 16 were met.¹

"Atopic dermatitis can be very burdensome and can impact patient and caregiver quality-of-life. New treatment options can bring renewed hope to the patient community," said Amanda Cresswell-Melville, Executive Director, Eczema Society of Canada.  

"As a leader in medical dermatology, I am delighted that LEO Pharma is able to offer Adtralza as a treatment option to people living with Atopic Dermatitis in Canada. The Health Canada approval represents our commitment to clinical trials and developing new medicines to treat skin diseases," said Gonçalo Goya, President and CEO, LEO Pharma Inc., Canada. "LEO Pharma continues to improve research and supports the ongoing development of treatments that advance the standard of care and reflect the actual needs of people living with skin diseases."

About Adtralza (tralokinumab)
Adtralza (tralokinumab) is a human, monoclonal antibody developed to specifically neutralize the IL-13 cytokine, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms.¹ 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). ^1,2

For more information, please refer to the product monograph for Adtralza in Canada located here.

About Atopic Dermatitis/Eczema⁶
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 helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit.

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, setting new standards of care for people with skin conditions.

LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company generated net sales of DKK 10,133 million.

For more information please visit www.LEO-Pharma.com.

References

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¹ Adtralza^® (tralokinumab) Canada Product Monograph. October 15, 2021. Available at: https://www.leo-pharma.ca/Files/Billeder/Adtralza%20PM%20-%2013%20OCT%202021.pdf

² Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62. Available at: https://onlinelibrary.wiley.com/doi/10.1111/all.13954

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. Available at: https://www.sciencedirect.com/science/article/pii/S0022283616305344?via%3Dihub

⁴ Wollenberg A, et al. Tralokinumab for moderate–to–severe atopic dermatitis: results from two 52–week, randomized, double–blind, multicentre, placebo–controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2020. Available at: https://onlinelibrary.wiley.com/doi/10.1111/bjd.19574

⁵ Silverberg JI, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate–to–severe atopic dermatitis: results from the double–blind, randomized, multicentre, placebo–controlled phase III ECZTRA 3 trial. Br J Dermatol. 2020. Available at: https://onlinelibrary.wile1y.com/doi/10.1111/bjd.19573

⁶ Eczema Society of Canada.  What is eczema?  Available at: https://eczemahelp.ca/about-eczema/

SOURCE LEO Pharma Canada

Contacts: Jill Archibald, VP, Sales and Marketing Dermatology, 905-220-6008, [email protected]; Henrik Kyndlev, Global External Communications, [phone], [email protected]