Galderma Receives Filing Acceptances for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in Four Additional Countries

• Galderma has received filing acceptances for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate-to-severe atopic dermatitis in Australia, Singapore, Switzerland, and the United Kingdom, via the Access Consortium framework
• The U.S. Food and Drug Administration and European Medicines Agency also accepted filing submissions for nemolizumab for the treatment of prurigo nodularis and atopic dermatitis in February 2024, with U.S. decisions anticipated this year
• Further submissions to regulatory authorities in additional countries are ongoing

ZUG, Switzerland--(BUSINESS WIRE)--Galderma today announced that it has received filing acceptances for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate-to-severe atopic dermatitis in Australia, Singapore, Switzerland, and the United Kingdom, whose regulatory authorities are members of the Access Consortium. An approval decision is expected from the consortium next year. Nemolizumab is a therapy specifically inhibiting IL-31 signaling to provide safe and rapid relief from the most burdensome symptom of both skin conditions: itch.^1-7

The Access Consortium is a collaborative initiative comprised of regulatory authorities which work together to address shared challenges, sharing knowledge and promoting greater collaboration to make regulatory systems more efficient.⁸

These acceptances are in addition to those received from the U.S. Food and Drug Administration (FDA) and European Medicines Agency for nemolizumab for the treatment of prurigo nodularis and atopic dermatitis in February 2024. Nemolizumab was also granted Breakthrough Therapy designation by the U.S. FDA in December 2019 for the treatment of pruritus associated with prurigo nodularis, a status reconfirmed in March 2023. The U.S. FDA subsequently granted nemolizumab Priority Review for the treatment of prurigo nodularis; its decisions on prurigo nodularis and atopic dermatitis are anticipated this year. Further submissions to regulatory authorities in additional countries are ongoing.

“These four new filing acceptances once again reinforce the potential blockbuster status of nemolizumab, which has shown great promise in both prurigo nodularis and atopic dermatitis. With even more filings anticipated this year, we are looking forward to finally bringing this long-awaited therapy to patients with these serious conditions as soon as possible, given the high burden of disease they still face.”   BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA

The regulatory submissions of nemolizumab in prurigo nodularis are based on data from the phase III OLYMPIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks in patients with prurigo nodularis.^9,10 Both trials in the OLYMPIA program met all primary and key secondary endpoints. Results demonstrated nemolizumab’s ability to rapidly improve itch, clear skin nodules and reduce sleep disturbance, with sustained improvements for up to one year.^11-13

The regulatory submissions of nemolizumab in atopic dermatitis are based on data from the phase III ARCADIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks in adolescents and adults with moderate-to-severe atopic dermatitis.^14,15 Both trials in the ARCADIA program met all primary and key secondary endpoints. Results showed that nemolizumab clinically improved skin lesions and rapidly improved itch and sleep disturbance.¹⁶

Media can find more information about atopic dermatitis and prurigo nodularis in this media toolkit.

About nemolizumab
Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 worldwide, except in Japan and Taiwan. In Japan, nemolizumab is approved for the treatment of pruritus associated with atopic dermatitis and is in development for prurigo nodularis. Nemolizumab is under regulatory review for the treatment of patients with prurigo nodularis and moderate-to-severe atopic dermatitis by the U.S. Food and Drug Administration and European Medicines Agency, as well as in Australia, Singapore, Switzerland, and the United Kingdom, via the Access Consortium framework. Galderma has not received regulatory approval for nemolizumab for any indication in any country to date.

About Galderma
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

1. Aggarwal P, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46(7):1277-1284. doi:10.1111/ced.14722
2. Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi:10.1016/j.anai.2018.07.006
3. Bağci IS and Ruzicka T. IL-31: A new key player in dermatology and beyond. J Allergy Clin Immunol. 2018;141(3):858-866. doi:10.1016/j.jaci.2017.10.045
4. Dillon SR, et al. Interleukin 31, a cytokine produced by activated T cells, induces dermatitis in mice [published correction appears in Nat Immunol. 2005;6(1):114]. Nat Immunol. 2004;5(7):752-760. doi: 10.1038/ni1084
5. Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi:10.1111/jdv.14570
6. Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi:10.1016/j.jaci.2019.08.013
7. Halvorsen JA, et al. Suicidal ideation, mental health problems, and social function in adolescents with eczema: a population-based study. J Invest Dermatol. 2014;134(7):1847-1854. doi:10.1038/jid.2014.70
8. SwissMedic.ch. Access Consortium. Available online: https://www.swissmedic.ch/swissmedic/en/home/about-us/international-collaboration/multilateral-co-operation-with-international-organisations---ini/multilateral-co-operation-with-international-organisations---ini.html Last accessed April 2024
9. ClinicalTrials.Gov. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Available online: https://clinicaltrials.gov/study/NCT04501679. Last accessed April 2024
10. ClinicalTrials.Gov. An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis. Available online: https://clinicaltrials.gov/study/NCT04501666. Last accessed April 2024
11. Kwatra SG, et al. Phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. doi: 10.1056/NEJMoa2301333
12. Ständer S, et al. Nemolizumab monotherapy improves itch and skin lesions in patients with moderate-to-severe prurigo nodularis: Results from a global phase 3 trial (OLYMPIA 1). Late-breaking abstract presented at EADV 2023
13. Kwatra, S, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: an interim analysis. Late-breaking abstract presented at AAD 2024
14. ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Available online: https://clinicaltrials.gov/study/NCT03989349. Last accessed April 2024
15. ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Available online: https://clinicaltrials.gov/study/NCT03985943. Last accessed April 2024
16. Silverberg J, et al. Nemolizumab improves skin lesions, itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis: Results from two identical phase 3 multinational studies (ARCADIA 1 and ARCADIA 2). Late-breaking abstract presented at EADV 2023