NICE Publishes Final Appraisal Document Recommending the Use of Adtralza® (tralokinumab) for Adult Patients With Moderate-to-Severe Atopic Dermatitis
LEO Pharma A/S, a global leader in medical dermatology, today announced that the National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) which recommends Adtralza® (tralokinumab) for use within NHS England and Wales. NICE recommends Adtralza for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients who are candidates for systemic therapy and have not responded to at least one systemic immunosuppressant, or these are not suitable.1
The NICE recommendation makes Adtralza the first and only recommended biologic for use within NHS England and Wales that specifically targets the interleukin (IL)-13 cytokine, a driver of AD signs and symptoms.1,2,3 AD affects approximately 3.5% of adults across Europe.7
“We are thrilled that today’s decision from NICE will help pave the way for atopic dermatitis patients in England and Wales to have access to Adtralza, as we continue to work alongside UK authorities to ensure reimbursement for this important therapy,” said Christophe Bourdon, Chief Executive Officer, LEO Pharma A/S. “As a global leader in medical dermatology, we are dedicated to ensuring that our efforts to introduce innovative therapies are matched with providing the necessary support for patients and their families who are living with this chronic and often debilitating condition.”
The evidence supporting the efficacy and safety profile of Adtralza comes from four randomized, multicenter, double-blind, placebo-controlled, Phase 3 studies: ECZTRA 1, ECZTRA 2, and ECZTRA 3 in patients with moderate-to-severe atopic dermatitis, and ECZTRA 7 in patients with severe atopic dermatitis.4,5,6
Adtralza was approved in June 2021 by the European Commission (EC) in Europe and by the Medicines & Healthcare products Regulatory Agency (MHRA) in Great Britain for adults with moderate-to-severe AD who are candidates for systemic therapy. The MHRA and EC decisions are valid in the UK and all European Union Member States, Iceland, Norway, and Liechtenstein. Adtralza also is approved for use in Canada, the United Arab Emirates, and Switzerland, and in the United States under the tradename AdbryTM. In January 2022, the Scottish Medicines Consortium (SMC) decided to reimburse Adtralza for use within NHS Scotland.
About the pivotal ECZTRA 1, 2, 3 and ECZTRA 7 Trials
ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the safety and efficacy of Adtralza (300 mg every other week) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.4
ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the safety and efficacy of Adtralza (300 mg every other week) in combination with TCS as needed in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.5
ECZTRA 7 (ECZema TRAlokinumab trial No. 7) was a double-blind, randomized, placebo-controlled, multinational 26-week trial, which included 277 adult patients, to demonstrate that Adtralza in combination with TCS is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).6
About atopic dermatitis
Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.8 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.9 Type 2 cytokines, including IL-13, play an important role in atopic dermatitis pathophysiology.3
About Adtralza® (tralokinumab)
Adtralza® (tralokinumab) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms. Adtralza specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).2,3
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 5,800 people, serving millions of patients across the world. In 2021, the company generated net sales of DKK 9,957 million.
References
- National Institute for Health and Care Excellence. 2022. Final appraisal document | Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis. Available at: < https://www.nice.org.uk/guidance/gid-ta10856/documents/final-appraisal-determination-document> [Accessed June 29 2022].
- Popovic B, et al. Structural Characterization reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017 Jan 20;429(2):208-219.
- Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54–62.
- 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.
- 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.
- Gutermuth J, et al. Tralokinumab plus topical corticosteroids in adults with severe atopic dermatitis and inadequate response to or intolerance of ciclosporin A: a placebo‐controlled, randomized, phase III clinical trial (ECZTRA 7). Br Journal of Dermatol. 2021.
- Barbarot, S., Auziere, S., Gadkari, A., Girolomoni, G., Puig, L., Simpson, E., Margolis, D., Bruin‐Weller, M. and Eckert, L., 2018. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy. 73(6), pp.1284-1293.
- Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine AD. Atopic dermatitis. Nat Rev Dis Primers. 2018 Jun 21;4(1):1.
- Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011; 242(1):233–46.
MAT-58207 June 2022
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220628006103/en/
Contact information
Henrik Heskjaer
LEO Pharma, Global External Communications
+45 3140 6180
HDTK@leo-pharma.com
David Patti
LEO Pharma, Global Product Communications
973.796.7706
DAPAI@leo-pharma.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Global Tourism Surging Ahead of Economic Growth, With Visits to Hit 30 Billion by 20344.7.2025 02:00:00 EEST | Press release
The World Economic Forum has today published a new report forecasting that the travel and tourism industry is projected to serve 30 billion tourist trips by 2034. Travel and Tourism at a Turning Point: Principles for Transformative Growth, produced in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, reveals a projected $16 trillion contribution to global GDP by the same year—representing more than 11% of the total world economy, according to World Travel & Tourism Council estimates. The report also found that the sector is expanding 1.5 times faster than the global economy, generating significant commercial opportunities as long as the mounting challenges of climate change, labour shortages and infrastructure gaps are addressed. Inbound and outbound trips increasing fast Asia is on track to become the world’s fastest-growing tourism economy, with the direct travel and tourism GDP contribution expected to exceed 7% across the region by 2034. Notably, India and China
The 2025-2026 World Branding Awards Animalis Edition Honouring Leading Pet and Animal Brands Globally3.7.2025 22:00:00 EEST | Press release
The 2025-2026 World Branding Awards Animalis Edition marked its fifth instalment, bringing together leading pet and animal brands from all around the world. These brands were celebrated for their outstanding achievements, earning recognition as National, Regional, and Global Winners. The awards ceremony, held at Vienna's prestigious Hofburg Palace, welcomed winners across diverse categories, including pet food, retail, wellness, pet exhibitions, and aquatic products. Mounia Berrada-Gouzi expertly hosted the evening, which culminated in a grand celebration of brand excellence. “The Animalis Edition of the World Branding Awards recognises brands that have achieved the highest distinction—genuine recognition in the hearts and minds of consumers. Tonight, we honour those whose names resonate globally, whose values inspire loyalty, and whose presence defines excellence in the pet and animal industry,” said Richard Rowles, Chairman of the World Branding Forum. Out of over 950 brands nominate
Venture Global Announces 20-Year Sales and Purchase Agreement with PETRONAS3.7.2025 15:59:00 EEST | Press release
Today, Venture Global, Inc. (NYSE: VG) announced the execution of a new 20-year Sales and Purchase Agreement (SPA) with PETRONAS LNG Ltd. (PLL), a subsidiary of the Malaysian state-owned oil and gas company, PETRONAS. Under the terms of the SPA, PETRONAS will purchase 1 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from Venture Global’s third facility, CP2 LNG, for 20 years. This builds upon Venture Global’s existing agreement with PETRONAS for 1 MTPA of LNG supply from Plaquemines LNG. PETRONAS, a world-class partner in the LNG industry, joins other CP2 LNG customers in Europe, Asia and the rest of the world in a strategically important project to global energy supply and security. To date, approximately 10.75 MTPA of the 14.4 MTPA nameplate capacity for CP2 Phase One has been sold. About Venture Global Venture Global is a long-term, low-cost provider of U.S. LNG sourced from resource rich North American natural gas basins. Venture Global’s business includes assets ac
Frost & Sullivan Recognizes Novotech as 2025 Global Biotech CRO Company of the Year3.7.2025 15:05:00 EEST | Press release
In recognition of its innovation, client-focused delivery, and global impact, Novotech has been awarded the 2025 Global Biotechnology Contract Research Organization (CRO) Company of the Year by Frost & Sullivan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703950144/en/ Novotech Wins Global CRO Award Novotech is a globally recognized full-service clinical CRO and scientific advisory firm, trusted by biotech and small- to mid-sized pharmaceutical companies to advance their drug development programs at every phase. With a global footprint spanning Asia-Pacific, North America, and Europe, Novotech supports over 5,000 clinical trial sites and a distributed team of experts delivering seamless, end-to-end solutions across geographies. “Novotech is redefining biotech-focused clinical research through AI-driven innovation, global expansion, and a client-embedded partnership model. With a clear vision to be the CRO of choice for
Tinnitus Research: Novel Compound AC102 Makes Constant Ear Noise Disappear in Preclinical Model3.7.2025 13:02:00 EEST | Press release
The novel compound AC102 almost completely reversed tinnitus in a preclinical model after a single dose. At the same time, the damaged connections between the auditory nerve and inner ear sensory cells were restored. These findings were recently published in the prestigious International Journal of Molecular Sciences in a joint study conducted by Erlangen University Hospital and Berlin-based drug developer AudioCure. As there is currently no causal treatment for tinnitus, there is a high medical need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702168211/en/ In 10-20% of tinnitus cases, the noise in the ear is so severe that it significantly impairs the quality of life of those affected. (Source: AI-generated) In the current study, AC102 was administered to the middle ear of one experimental group after acoustic trauma, while a second group received a placebo. Although both groups initially showed signs of tinnitus, th
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom