RAD 2025: Long-Term Data on Nemluvio® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years
ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD) today announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio in moderate-to-severe atopic dermatitis. The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years.1 These data will be presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference, taking place from June 6-7, 2025.
|
“With Nemluvio now being launched in several countries, it’s so encouraging that we continue to see its robust evidence base expand. Long-term data is pivotal to this, highlighting the profound impact this innovative treatment can have in atopic dermatitis well into the future.” BALDO SCASSELLATI SFORZOLINI, M.D., PHD. GLOBAL HEAD OF RESEARCH & DEVELOPMENT GALDERMA |
|
Atopic dermatitis affects more than 230 million people worldwide.3 Often reported as one of patients’ most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians.4-7 Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.3,8,9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis.8,10 Nemluvio is also the first and only biologic approved for atopic dermatitis as well as prurigo nodularis with four-week dosing intervals from the start of treatment, and the only option to move to eight-week dosing intervals for appropriate patients with atopic dermatitis.9
|
“The relentless itch of atopic dermatitis is not just a symptom; it's a constant burden that disrupts sleep, concentration, and the simple joys of life. Nemolizumab has demonstrated its impact on both itch and skin lesions in atopic dermatitis extensively over the years, and these new data, demonstrating its benefit up to two years, add another layer of confidence to that.” |
|
The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe atopic dermatitis up to five years and includes more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients.1
Results to be presented at the RAD Conference will show that Nemluvio is associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years.1 At week 104 in evaluable patients, the interim analysis shows that:
Results also reinforce Nemluvio’s rapid onset of action on itch and skin at Week 4, with 49% of patients who entered the long-term extension study naïve to Nemluvio achieving a 75% reduction in the EASI, and 69% achieving an at least four-point improvement in itch when assessed using the SCORAD VAS Pruritus score.1
Nemluvio was well tolerated in the long-term treatment of atopic dermatitis and no new safety signals were identified.1
Additional data from both the ARCADIA program in atopic dermatitis, as well as from the OLYMPIA open-label extension study in prurigo nodularis will be presented at RAD 2025, reinforcing Nemluvio’s rapid impact on key symptoms of atopic dermatitis, and its long-term efficacy in prurigo nodularis.11,12
Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis.9 In December 2024, it was also approved by the U.S. FDA for the treatment of 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.9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional regulatory submissions and reviews are ongoing.
More details on Galderma’s scientific presentations at RAD can be found here.
About Nemluvio
Nemluvio 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.13,14
About atopic dermatitis
Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.3,15,16 It affects more than 230 million people worldwide.3 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.17
Important Safety Information
Indications: NEMLUVIO® (nemolizumab-ilto) is a prescription medicine used:
Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
The most common side effects of NEMLUVIO include:
These are not all of the possible side effects of NEMLUVIO.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088.
Please see full Prescribing Information including Patient Information.
About Galderma
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: www.galderma.com.
References