LEO Pharma announces MHRA and EC approval of Adtralza▼ (tralokinumab) as the first and only treatment specifically targeting IL-13 only for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy

LEO Pharma announces MHRA and EC approval of Adtralza▼ (tralokinumab) as the first and only treatment specifically targeting IL-13 only for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy

• The approval is primarily supported by data from the ECZTRA 1, 2 and ECZTRA 3 phase 3 trials, in which Adtralza (tralokinumab) demonstrated significant improvements versus placebo in atopic dermatitis signs and symptoms, with response rates maintained and gradually improved over time1,2
• Tralokinumab was generally well tolerated with an overall frequency and severity of adverse events comparable with placebo1,2
• Tralokinumab was also shown to reduce itch and improve patients Dermatology Life Quality Index (DLQI)1

Hurley, Berks, UK, 22 JUNE, 2021 – LEO Pharma UK and Ireland, a leader in medical dermatology, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) has approved tralokinumab for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. The MHRA and EC approvals make tralokinumab the first and only approved biologic that specifically targets the IL-13 cytokine alone, a key driver of atopic dermatitis signs and symptoms.3,4

Tralokinumab is the first high affinity, human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine in adult patients with uncontrolled moderate-to-severe atopic dermatitis.1,3,4 Tralokinumab 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.5 Tralokinumab can be used with or without topical corticosteroids (TCS).5

“Atopic dermatitis can be an intensely itchy, challenging and unpredictable skin condition for some. As clinicians, we always want more options for patients and the approval of tralokinumab means that clinicians across the UK and Ireland now have an important new treatment option for patients with moderate-to-severe atopic dermatitis in adult patients” said, Professor Anthony Bewley, Consultant Dermatologist at Barts Health NHS Trust.

The MHRA and EC approval of tralokinumab is a significant milestone for thousands of adults in Europe living with atopic dermatitis,” said Dr. Amit Aggarwal, Medical Director, LEO Pharma UK and Ireland. “Tralokinumab was developed based on the advanced understanding of the immune processes underlying atopic dermatitis, which is fundamental to our mission of pioneering medical dermatology” he continued.

The approval is based primarily on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included more than 1,900 adult patients with moderate-to-severe AD.5 Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose ranging trial, and a vaccine response trial.5

LEO Pharma is working closely with key stakeholders to support access to tralokinumab for eligible patients.

The MHRA and EC decisions are valid in the UK and all European Union Member States, Iceland, Norway, and Liechtenstein. Additional regulatory filings are underway with [the U.S. Food and Drug Administration (FDA) and other] health authorities worldwide.1

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.6 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.7 Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.3

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 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.

Contacts

 Alex Orton

Communications and Patient Engagement Manager

LEO Pharma

+44 7767 277474

AAOUK@leo-pharma.com

Sam Coldicutt Account Manager

WE Communications

+44 7632 3838

scoldicutt@we-worldwide.com

References

1. 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. 2021; 437-449.
2. 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. 2021; 450-463.
3. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
4. 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.
5. SmPC Guidance. Adtralza® (tralokinumab) 2021, Avaliable at: https://ec.europa.eu/health/documents/community- register/2021/20210617151835/anx_151835_en.pdf
6. Weidinger S, et al. Atopic dermatitis. Lancet. 2016; 387:1109-1122.
7. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.

June 2021 MAT-47451