BUSINESS WIRE: Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and EU

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• The U.S. Food and Drug Administration (FDA) has accepted Galderma’s Biologics License Applications for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis.
• Nemolizumab was granted U.S. FDA Priority Review for prurigo nodularis.
• The European Medicines Agency has also accepted the Marketing Authorization Applications for nemolizumab in prurigo nodularis and atopic dermatitis.
• Further submissions to regulatory authorities in additional countries are planned in 2024.

ZUG, Switzerland --(BUSINESS WIRE)-- 14.02.2024 --

Galderma today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Applications for nemolizumab for the treatment of prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis. Nemolizumab is a first-in-class investigational monoclonal antibody specifically designed to inhibit IL-31 signaling to provide safe and rapid relief from the most burdensome symptom of both skin conditions: itch.^1-7

The U.S. FDA has granted nemolizumab Priority Review for the treatment of prurigo nodularis. This follows its designation as a Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis, originally granted in December 2019 and reconfirmed in March 2023. Priority Review is granted for medicines that would significantly improve the treatment, diagnosis or prevention of serious conditions.

The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab in both prurigo nodularis and atopic dermatitis. Galderma is planning for multiple regulatory submissions in 2024.

“The relentless itch experienced by many people living with prurigo nodularis and atopic dermatitis has a significant impact on their overall quality of life. We are thankful to the patients and medical experts whose insights informed our clinical trials, which assessed nemolizumab’s ability to reduce the symptoms of itch and skin lesions. We are one step closer to delivering this innovative solution to those in need and look forward to the outcomes of these filing decisions.”

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.^8,9

Results from the OLYMPIA program demonstrated nemolizumab’s ability to rapidly improve itch, clear skin nodules and reduce sleep disturbance.

In the OLYMPIA program, patients treated with nemolizumab monotherapy showed clinically and statistically significant improvements in both primary endpoints compared to placebo after 16 weeks of treatment:^10,11

• More than half of nemolizumab-treated patients achieved an at least four-point reduction in itch intensity, as measured by the peak-pruritus numerical rating scale (PP-NRS; 8% and 56% in OLYMPIA 1 and 2, respectively, compared to 17% and 21% in the placebo groups; p<0.0001).
• On average, a third of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment (IGA) score (26% and 38% in OLYMPIA 1 and 2, respectively, compared to 7% and 11% in the placebo groups; p<0.0001).

The trials also met all key secondary endpoints confirming rapid onset of action on itch and sleep disturbance within four weeks of treatment initiation:

• 41% of nemolizumab-treated patients achieved an at least four-point reduction in itch in both the OLYMPIA 1 and 2 studies, as measured by the PP-NRS score, compared to 6% and 8% in the placebo groups (p<0.0001), respectively.
• In OLYMPIA 2, nearly four times as many patients in the nemolizumab-treated group (37%) versus placebo (10%) achieved significant and clinically meaningful improvements in sleep disturbance, as measured by a four-point improvement on the sleep disturbance numerical rating scale (SD-NRS; p<0.0001).

The phase III OLYMPIA clinical trial program is the largest clinical trial program conducted in prurigo nodularis to date, with more than 500 patients enrolled, and the only one to include a long-term extension study.

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.^12,13

In the ARCADIA program, nemolizumab clinically improved skin lesions and rapidly improved itch and sleep disturbance.

Both ARCADIA trials showed clinically and statistically significant improvements in co-primary endpoints, compared to placebo, after 16 weeks of treatment:¹⁴

• More than a third of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions when assessed using the IGA score (36% and 38% in ARCADIA 1 and 2, respectively, compared to 25% and 26% in the placebo groups; p<0.001).
• More than 40% of nemolizumab-treated patients achieved a 75% reduction in the Eczema Area and Severity Index (44% and 42% in ARCADIA 1 and 2, respectively, compared to 29% and 30% in the placebo groups; p<0.001).

The trials also met all key secondary endpoints confirming rapid onset of action on itch and sleep disturbance, with statistically significant and clinically meaningful improvements observed as early as one week after treatment initiation. Results at week 16 showed:

• Nearly half of nemolizumab-treated patients achieved an at least four-point reduction in itch intensity as measured by the PP-NRS score (49% and 48% in ARCADIA 1 and 2, respectively, compared to 21% in the placebo groups; p<0.0001, MI-MAR analysis).
• 44% and 38% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved an at least four-point reduction in sleep disturbance as measured by the SD-NRS score (compared to 22% and 20% in the placebo group; p<0.001, MI-MAR analysis).

Nemolizumab was generally well tolerated and its safety profile was similar to placebo across the OLYMPIA and ARCADIA clinical trial programs.^10,11,14

About prurigo nodularis
Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.^5,15-16 Prurigo nodularis is an underrecognized and underdiagnosed skin disease.^15,17

About the OLYMPIA phase III clinical trial program
The OLYMPIA program included two identical, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2.^8,9 These global, randomized, double-blind, placebo-controlled phase III clinical trials assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with moderate-to-severe prurigo nodularis after a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively.^8,9 The two phase III OLYMPIA trials met all primary and key secondary endpoints.^10,11 Results showed that treatment with nemolizumab monotherapy resulted in significant and clinically meaningful improvements on itch, sleep disturbance and skin lesions in adult patients with prurigo nodularis, with early and sustained improvements on itch observed by week four.^10,11

About atopic dermatitis
Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.^19,20 It impacts more than 230 million people worldwide and is the most common inflammatory skin disease.¹⁹

About the ARCADIA phase III clinical trial program
The ARCADIA program included two identical, pivotal phase III clinical trials which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2.^12,13 These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroid therapy or topical calcineurin inhibitors).^12,13 The trials were conducted in adolescent (12 years and over) and adult patients with moderate to severe atopic dermatitis for an initial treatment phase of 16 weeks, followed by a maintenance treatment phase for up to 48 weeks.^12,13 The two phase III ARCADIA trials met their co-primary endpoints and all key secondary endpoints, demonstrating that nemolizumab rapidly and significantly improves itch, skin lesions and sleep disturbance in patients with moderate to severe atopic dermatitis.¹⁴

About nemolizumab
Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 worldwide, except 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 with the U.S. Food and Drug Administration and European Medicines Agency.

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. 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 February 2024
9. ClinicalTrials.Gov. An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis. Available online: https://clinicaltrials.gov/study/NCT04501666 Last accessed February 2024
10. Kwatra SG, et al. Placebo-controlled phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. DOI: 10.1056/NEJMoa2301333
11. 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.
12. ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Available online: https://clinicaltrials.gov/study/NCT03989349. Last accessed February 2024
13. ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Available online: https://clinicaltrials.gov/study/NCT03985943 Last accessed February 2024
14. 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
15. Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi:10.1016/j.jaad.2020.04.183
16. Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi:10.1097/itx.0000000000000042
17. Kwatra SG, et al. Patient journey and the burden of systemic comorbidities and sequalae in prurigo nodularis. J Drugs Dermatol. 2023;22(12): 12-14. doi:10.36849/JDD.SF365502
18. Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi:10.1016/S0140-6736(20)31286-1
19. Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911

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Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50

Sébastien Cros
Corporate Communications Director
sebastien.cros@galderma.com
+41 79 529 59 85

Emil Ivanov
Head of Strategy, Investor Relations, and ESG
emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen
Investor Relations and Strategy Director
jessica.cohen@galderma.com
+41 21 642 76 43