The National Institute for Health and Care Excellence (NICE) has published a Positive Final Assessment Document (FAD) recommending Adtralza® ▼ (tralokinumab) for use within NHS England and Wales.
Treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic treatment is recommended only if the disease does not respond to at least one systemic immunosuppressive drug or if these are not appropriate. 3
This occurs at a critical time when atopic dermatitis affects about 3.5% of adults across Europe. 7 According to a survey earlier this year, people with atopic dermatitis in the UK will be happy to replace 37% of their remaining lifespan to achieve better health. 8
Tralokinumab is the first high-affinity human developed to specifically bind and inhibit IL-13 cytokines in adult patients with uncontrolled moderate to severe atopic dermatitis, a candidate for systemic therapy. It is a monoclonal antibody. 1,2 Tralokinumab is provided in a 150 mg / mL prefilled syringe for subcutaneous injection, with an initial dose of 600 mg and then biweekly 300 mg. 9 Tralokinumab can be used with or without topical corticosteroids (TCS).9
Sarah Kleinpeter, Vice President and General Manager of LEOPharma, UK and Ireland, said: We are pleased that this recommendation will make new treatment options available to people living in England and Wales. This approval represents the latest innovation by LEO Pharma, which continues to support people with skin conditions. We would like to thank all LEO Pharma employees and partners, as well as the clinicians and patient groups who have worked hard to support this process for our patients. “
Professor Anthony Bewley, a dermatology consultant at the Barts Health NHS Trust, said: This recommendation is an important step in providing important new treatment options for patients with atopic dermatitis and improving their experience and quality of life in England and Wales. “
Andrew Proctor, Chief Executive Officer of the National Eczema Society, said: .. “
- The structural features of Popovich B et al. Reveal the mechanism of the IL-13 neutralizing monoclonal antibody tralokinumab as an inhibition of binding to IL-13Rα1 and IL-13Rα2. JMol Biol. January 20, 2017; 429 (2): 208-219.
- Bieber T. Interleukin-13: Targets cytokines that are underestimated in atopic dermatitis. allergy. 2020; 75: 54–62.
- National Institute for Health and Care Technology. Final Assessment Document-Abrocitinib, Tralokinumab, Upadacitinib for the treatment of moderate to severe atopic dermatitis. June 2022.
- Wollenberg A, et al. Tralokinumab for moderate to severe atopic dermatitis: Results of two randomized, double-blind, placebo-controlled phase III trials (ECZTRA1 and ECZTRA2) for 52 weeks. BrJ Dermatol. 2021; 437–449.
- Silverberg JI, et al. Tralokinumab and topical corticosteroids for the treatment of moderate to severe atopic dermatitis: double-blind, randomized, multicenter, placebo-controlled phase III ECZTRA3 trial results. BrJ Dermatol. 2021; 450-463.
- Gutermuth J, et al. Tralokinumab and topical corticosteroids in adults with inadequate response or intolerance to severe atopic dermatitis and cyclosporine A: a placebo-controlled, randomized, phase III clinical trial (ECZTRA7). 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 Onset of atopic dermatitis in adults: results of international research. Allergies, 73 (6), pp.1284-1293.
- Global Patient Initiative for Improved Eczema Care Dashboard 2022, available at https://www.improveeczemacare.com/dashboard
- SmPC guidance. Available at Adtralza® 2021, https: //www.ema.europa.eu/en/documents/product-information/adtralza-epar-productinformation_en.pdf
NICE Approves LEO Pharma’s Dermatitis Treatment in India and Wales
Source link NICE Approves LEO Pharma’s Dermatitis Treatment in India and Wales