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Key takeaways:
Nemluvio’s approved indications include atopic dermatitis in patients aged 12 years and older and prurigo nodularis in adults.
The approvals are supported by two phase 3 clinical trial programs.
Nemluvio has received approval from the European Commission to treat moderate to severe atopic dermatitis and prurigo nodularis in the European Union, Galderma announced in a press release.
A second press release detailed that the drug was also granted marketing authorization for the same indications from two countries within the Access Consortium framework: the United Kingdom and Switzerland.
The European Commission has approved Nemluvio for moderate to severe atopic dermatitis and prurigo nodularis.
Nemluvio (nemolizumab, Galderma) is now indicated for the subcutaneous treatment of moderate to severe AD in patients aged 12 years and older who are candidates for systemic therapy as well the subcutaneous treatment of moderate to severe prurigo nodularis in adults.
Christophe Piketty
“The approvals of Nemluvio for patients with moderate to severe atopic dermatitis and patients with prurigo nodularis … are important and exciting,” Christophe Piketty, MD, PhD, global program head at Galderma, told Healio. “We know there is an urgent need for new treatment options for these diseases — treatments that will effectively relieve debilitating symptoms like persistent itch, skin lesions and sleep disturbance, which all contribute to poor quality of life.”
These approvals make Nemluvio the first monoclonal antibody and interleukin-31 inhibitor indicated for the treatment of both of these IL-31-driven diseases in the European Union, U.K. and Switzerland and the first biologic for these conditions that allows for 4-week dosing intervals from the start of treatment, according to the release.
These approvals are supported by results from the phase 3 ARCADIA and OLYMPIA clinical trial programs.
In the ARCADIA trials, patients with AD that were treated with subcutaneous Nemluvio every 4 weeks in combination with background topical corticosteroids with or without topical calcineurin inhibitors achieved statistically significant skin clearance by week 16 compared with those treated with placebo in combination with the same topicals.
According to the release, Nemluvio was also able to significantly lower itch responses as early as week 1 and improved sleep disturbances.
Nemluvio monotherapy demonstrated similar results in the OLYMPIA trials where patients with prurigo nodularis exhibited clinically meaningful improvements in itch and skin lesions by week 16 compared with placebo-treated patients. Patients in the OLYMPIA trials also saw an improvement in sleep disturbances within 4 weeks of beginning treatment.
Nemluvio maintained a consistent safety profile characterized as well-tolerated across the trials.
While approved in the U.S. for AD and prurigo nodularis, Nemluvio is still under review by other country’s national health authorities including in Canada, Brazil and South Korea, as well as in the remaining two countries in the Access Consortium, Australia and Singapore.
“We expect decisions in the remaining countries in the Access Consortium later this year,” Piketty said. “We are hopeful about seeing more approvals and then launches soon.”
Reference:
Perspective
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The approval of nemolizumab in the European Union, U.K. and Switzerland signifies continued forward progress in our ability to deliver targeted, pathogenesis-driven treatments to our patients with skin disease. As a blocker of IL-31 signaling, nemolizumab is an especially welcome addition to the systemic therapy space for both AD and prurigo nodularis given the dominant role that itch plays in both of these chronic conditions.
Raj Chovatiya, MD, PhD
Clinical Associate Professor at Rosalind Franklin University Chicago Medical School
Founder and director of the Center for Medical Dermatology and Immunology Research
Disclosures: Chovatiya reports serving as an advisor, consultant, speaker, and/or investigator for AbbVie, Acelyrin, Alumis, Amgen, AnaptysBio, Apogee Therapeutics, Arcutis Biotherapeutics Inc., Argenx, Astria Therapeutics Inc., Avalere Health, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, CLn Skin Care, Dermavant, Eli Lilly and Company, EMD Serono, Formation Bio, Galderma, Genentech, GSK, Incyte, Johnson & Johnson, Kenvue, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc., RAPT, Regeneron, Sanofi, Sitryx, Takeda, TRex Bio, and UCB.
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Publish date : 2025-02-19 11:27:00
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