New Published Data Confirms Nemluvio® (Nemolizumab) Can Rapidly Relieve Itch and Improve Sleep in as Early as Two Days in Both Atopic Dermatitis and Prurigo Nodularis

Author of the article:You can save this article by registering for free here. Or sign-in if you have an account.Subscribe now to read the latest news in your city and across Canada.Subscribe now to read the latest news in your city and across Canada.Create an account or sign in to continue with your reading experience.Create an account or sign in to continue with your reading experience.ZUG, Switzerland — Galderma (SIX: GALD), the pure-play dermatology category leader, today released new clinical data confirming nemolizumab’s rapid onset of action on itch and sleep, with significant improvements observed as early as 48 hours after treatment in some patients with atopic dermatitis and prurigo nodularis.1 The findings from post-hoc analyses of the phase III ARCADIA and OLYMPIA clinical trial programs were published in the Journal of the European Academy of Dermatology and Venereology.Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againInterested in more newsletters? Browse here.Nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signalling of IL-31.2,5,6 IL-31 is a neuroimmune cytokine that drives itch and other symptoms in both atopic dermatitis and prurigo nodularis.3,4 These new findings reinforce the critical role of IL-31 pathway inhibition in achieving rapid itch response.Atopic dermatitis and prurigo nodularis are debilitating skin conditions that significantly affect quality of life, with symptoms such as persistent itch, skin lesions and poor sleep quality.7-13 Itch is one of the most burdensome symptoms of both conditions, with 87% of patients with atopic dermatitis seeking freedom from itch, and 88% of those with prurigo nodularis rating it as their worst symptom.13,14“These new data reinforce our understanding of nemolizumab’s rapid onset of action in relieving itch and, in turn, improving sleep in patients living with atopic dermatitis and prurigo nodularis, as well as its role in targeting the IL-31 pathway. We are proud to be driving innovation that directly addresses the most urgent needs of people living with chronic skin conditions and remain committed to delivering effective, fast-acting and lasting solutions.”CHRISTOPHE PIKETTY, M.D., PH.D.AUTHOR AND GLOBAL PROGRAM HEAD THERAPEUTIC DERMATOLOGYGALDERMATaken individually, each study (ARCADIA 1 and 2 for atopic dermatitis and OLYMPIA 1 and 2 for prurigo nodularis) also demonstrated a significant PP-NRS response at Day 2.1 These new data reinforce nemolizumab’s efficacy and its potential to deliver rapid relief from itch – the most burdensome symptom for many patients with atopic dermatitis and prurigo nodularis.13,14 Media can find more information and resources on atopic dermatitis and prurigo nodularis in this toolkit.About Nemluvio® (nemolizumab) Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.15,16 Nemluvio was approved by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis, and patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.5 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including in the European Union, Australia, Singapore, Switzerland and the United Kingdom. Additional regulatory submissions and reviews are ongoing.The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2.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 corticosteroids with or without topical calcineurin inhibitors).The trials were conducted in adolescent and adult patients (12 years and over) with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks. Patients who responded to treatment (defined as patients who achieved an investigator’s global assessment score of clear (0) or almost clear (1), or a 75% or greater improvement in the eczema area and severity index score) were then re-randomized to a maintenance treatment phase for up to 48 weeks.is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.It affects approximately 10 to 40 million people in the European Union, with up to 66% of adults suffering with a moderate-to-severe form of the condition.The OLYMPIA program included two identically designed, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study.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 over a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively.is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.It is estimated to affect between 7-111 people per 100,000 in the European Union depending on the country.The majority of patients report that the persistent itch negatively impacts their quality of life.Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life.Galderma (SIX: GALD) is the 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:. https://www.businesswire.com/news/home/20251216808770/en/ContactsFor further information: Christian Marcoux, M.Sc.

Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50Richard Harbinson Corporate Communications Director richard.harbinson@galderma.com +41 76 210 60 62Céline Buguet Franchises and R&D Communications Director celine.buguet@galderma.com +41 76 249 90 87Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43#distroPostmedia is committed to maintaining a lively but civil forum for discussion. Please keep comments relevant and respectful. Comments may take up to an hour to appear on the site. You will receive an email if there is a reply to your comment, an update to a thread you follow or if a user you follow comments. Visit our Community Guidelines for more information.