ZUG, SWITZERLAND -- Galderma (SIX: GALD) announced new data from the OLYMPIA open-label extension study investigating the long-term safety and efficacy of Nemluvio in moderate-to-severe prurigo nodularis.1 Results showed that Nemluvio maintained long-term disease control and a well-tolerated safety profile, with clinically meaningful improvements in itch intensity, skin lesions and quality of life up to three years.[1] Results will be presented at 2026 Winter Clinical Miami and build on previous data from OLYMPIA - the largest completed pivotal clinical program in prurigo nodularis and the only one with a LTE study.[1],[6],[7]

“Prurigo nodularis is not only intensely itchy, painful and uncomfortable, it can also take a profound toll on sleep, emotional wellbeing, and daily functioning. That’s why achieving sustained, long-term disease control is critical for patients. These data show that Nemluvio can make a meaningful difference to people’s lives by improving itch, skin lesions and quality of life up to three years, with a well-tolerated safety profile.”

DOCTOR SHAWN KWATRA, M.D.
LEAD INVESTIGATOR OF OLYMPIA PROGRAM
JOSEPH W. BURNETT ENDOWED PROFESSOR AND CHAIRMAN OF DERMATOLOGY UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE

The OLYMPIA LTE study was designed to assess the safety and efficacy of Nemluvio in patients with prurigo nodularis up to four years and included 508 patients from the phase II trial and the OLYMPIA 1 and 2 phase III trials.1 At Week 148, in evaluable patients, the interim analysis showed that Nemluvio maintained long-term disease control with a consistent safety profile:

·Over 70% of patients achieved clear or almost clear skin lesions based on Investigator’s Global Assessment score, and over 85% achieved more than 75% of healed lesions based on prurigo activity score.[1]
·Over 85% of patients achieved a clinically meaningful itch improvement, and about three-quarters attained an itch-free or nearly itch-free state.[1]
·About 90% of patients achieved a clinically meaningful improvement in quality of life, and >50% achieved a Dermatology Life Quality Index score of zero or one, meaning no effect of the disease on quality of life.[1]
·The long-term safety profile of Nemluvio remained consistent with previous findings and aligned with previously established safety data for prurigo nodularis.[1]

“We recognize that prurigo nodularis is a chronic, debilitating condition that patients often struggle with for many years. Our goal has always been to generate robust, long-term evidence on how to ease such disease burden for patients suffering from prurigo nodularis, drawing on data from the largest completed pivotal clinical program and now the longest extension study reported in this disease to date.”

BALDO SCASSELLATI SFORZOLINI, M.D., PH.D.
GLOBAL HEAD OF R&D
GALDERMA

Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.[2-5] IL-31 is a neuroimmune cytokine that drives itch and other symptoms in prurigo nodularis.[2-5] Nemluvio is approved by multiple regulatory authorities around the world for the treatment of prurigo nodularis and moderate-to-severe atopic dermatitis, including in the U.S. and EU.[4],[5]