EBGLYSS® (lebrikizumab) is ranked as number one of the interleukin-inhibitors for severe atopic dermatitis in adults and adolescents on TNF BIO 2406b from May 1, 2024

OSLO, Norway. May 28^th, 2024 –Almirall, a global pharmaceutical company dedicated to medical dermatology announced today the launch of lebrikizumab (EBGLYSS) in Norway, the first country in the Nordic region where lebrikizumab will be available as a prescription medicine. The biologic is ranked as number one of the interleukin-inhibitors for severe atopic dermatitis in adults and adolescents on TNF BIO 2406b from May 1, 2024.^1,2

The recommendations for TNF BIO 2406b as of May 1, 2024 apply to Helse Vest RHF, Helse Midt-Norge RHF, Helse Nord RHF and Helse Sør-Øst RHF^1,2. These recommendations are based on a previous decision from the Decision Forum for New Health Technologies on March 18, 2024. The Decision Forum has decided that lebrikizumab (EBGLYSS) should be introduced for the treatment of severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older with a body weight of at least 40 kg who are eligible for systemic treatment.³

The pharmaceutical company Almirall starts the Nordic launch in Norway.

Lebrikizumab is a monoclonal antibody that binds to IL-13 with high affinity and selectively inhibits downstream signaling, ^4,5,6,7 which inhibits the biological action of IL-13. IL-13 plays an important role in atopic dermatitis and drives the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, pruritus, skin thickening and infection.^5,8,9,10,11. Lebrikizumab has demonstrated clinical efficacy and sustained response in patients with moderate to severe atopic dermatitis up to week 52 in both monotherapy and in combination with topical corticosteroids ^{12,13,14,15,16} with maintenance dosing every 4 weeks from week 24.

- "With EBGLYSS ranked as number one of the interleukin inhibitors for severe atopic dermatitis in adults and adolescents on TNF BIO, healthcare professionals have a new first-line treatment option among interleukin inhibitors for patients with severe atopic dermatitis," said Christian Bruun-Andersen, General Manager of Almirall Nordic, adding: - "I am confident that EBGLYSS can have a positive impact on the lives of patients with severe atopic dermatitis.

 Kåre Steinar Tveit, Consultant, Department of Dermatology, Haukeland Hospital, says:

- There has been a need for new treatment options for atopic dermatitis. It is important for us to be able to offer our patients this new tool, which can contribute to better management of their condition and improve their quality of life.

About the lebrikizumab clinical development program

The lebrikizumab Phase 3 trials consisted of five global studies evaluating over 1,300 patients, including two monotherapy studies (ADvocate 1 and 2), a topical corticosteroid combination study (ADhere), a long-term follow-up study (ADjoin) and an open-label study in adolescents (ADore).

About atopic dermatitis (AD)

AD is an inflammatory, chronic skin disease characterized by recurrent inflammation of the skin with itching or severe pruritus. In addition to physical symptoms such as dryness, itching, red rash and inflammation, AD also has significant emotional consequences for patients that can affect education, social and professional life.¹⁵ With a prevalence of up to 4.4% among adults in the EU, 10.4% of 18-year-olds in Norway and 14% of adults in Sweden, the prevalence of AD has risen in recent decades, with 20-30% of patients experiencing moderate to severe AD.^{15,17,18,19,20,21}

Media contact

corporate.communication@almirall.com

Links to Almirall

Almirall's Norwegian newsroom for journalists: https://www.mynewsdesk.com/no/almirall-ab

Almirall Nordics https://nordics.almirall.com

Almirall, S.A. www.almirall.com

Almirall S.A press room www.almirall.com/media

About Almirall

Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs.

Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Almirall (total revenue in 2023: €898.8 MM, 1900 employees globally) has a direct presence in 21 countries and affiliates in over 70 others.

For more information, please visit almirall.com

Legal warning

This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are "forward-looking statements". These statements are based on the information currently available and the best estimates and assumptions that the company considers reasonable. These statements involve risks and uncertainties beyond the control of the company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law.

Sources

1.            Sykehusinnkjøp HF. TNF-BIO Helse Nord- og Sør-Øst [Internet]. May 2024 [accessed May 2024]. Available from https://www.sykehusinnkjop.no/siteassets/ avtaledokumenter/avtaler-legemidler/tnf-bio/tnfbio-helse-nord-og-sor-ost. pdf

2.            Sykehusinnkjøp HF. TNF-BIO Helse Vest og Midt. [Internet]. May 2024 [accessed May 2024]. Available from: https://www.sykehusinnkjop.no/siteassets/ avtaledokumenter/avtaler-legemidler/tnf-bio/tnfbio-helse-vest-og-midt.pdf

3.            Decision Forum for New Approaches, Minutes 18 March 2024. Case 007-2024 Ref. ID2023_058

4.            Moyle M, et al. Understanding the immune landscape in atopic dermatitis: The era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019 Jul;28(7):756-68.

5.            Gonçalves F, et al. Selective IL-13 inhibitors for the treatment of atopic dermatitis. Drugs Context 2021;10:2021-1-7.

6.            Okragly A, et al. Binding, Neutralization and Internalization of the Interleukin-13 Antibody, Lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535-1547.

7.            Ultsch M, et al. Structural Basis of Signaling Blockade by Anti-IL-13 Antibody Lebrikizumab. J Mol Biol. 2013;425(8):1330-1339.

8.            Tsoi LC, et al. Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. J Invest Dermatol. 2019;139(7):1480-1489.

9.            Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020 Jan;75(1):54-62.

10.          Napolitano M, et al. The hidden sentinel of the skin: An overview on the role of interleukin-13 in atopic dermatitis.Front Med (Lausanne). 2023;10:1165098.

11.          Bernardo D, et al. Lebrikizumab for the Treatment of Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2023;24, 753-764.

12.          Silverberg JI, et al. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. N Engl J Med. 2023 Mar 23;388(12):1080-91.

13.          Simpson EL, et al. Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere). JAMA Dermatol. 2023 Feb 1;159(2):182-91

14.          Blauvelt A, et al. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52-week results of two randomized double-blinded placebo-controlled phase III trials. Br J Dermatol. 2023 May 24;188(6):740-8. https://doi.org/10.1093/bjd/ljad022

15.          Koszorú K, Borza J, Gulácsi L, Sárdy M. Quality of life in patients with atopic dermatitis. Cutis. 2019 Sep;104(3):174-177.

16.          EBGLYSS (lebrikizumab). Summary of Product Characteristics. Almirall, November 2023.

17.          Barbarot S, et al. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy. 2018 Jun;73(6):1284-93.

18.          Silverberg J, et al. Atopic dermatitis in the pediatric population: A cross-sectional, international epidemiologic study. Ann Allergy Asthma Immunol 2021;126(4):417-428.

19.          Munera-Campos M, et al. Innovation in Atopic Dermatitis: From Pathogenesis to Treatment. Actas Dermosifiliogr. 2020;111(3):205-221. 

20.          Sørensen et al. Allergic disease and Staphylococcus aureus carriage in adolescents in the Arctic region of Norway. PAI. Volume 27, Issue 7 November 2016. Pages 728-735

21.          Theodosiou et al. Burden of Atopic Dermatitis in Swedish Adults: A Population-based Study. Acta Derm Venereol 2019 Oct 1;99(11):964-970. doi: 10.2340/00015555-3257.