Galderma’s Nemluvio® (nemolizumab) has received FDA approval for moderate-to-severe atopic dermatitis in patients aged 12 and older, offering a novel treatment option targeting IL-31.
According to a press release from Galderma, the approval follows results from the phase III ARCADIA trial program, which evaluated Nemluvio in combination with topical corticosteroids (TCS) with or without calcineurin inhibitors (TCI) in 1,728 patients. Those treated with Nemluvio achieved statistically significant improvements in skin clearance, with 75% achieving a reduction in Eczema Area and Severity Index (EASI) scores and clearance or near-clearance on the investigator’s global assessment (IGA) scale compared to placebo after 16 weeks. Early itch relief was observed as soon as week 1, alongside improvements in sleep disturbance. Nemluvio was well tolerated.
“Despite currently available treatment options, atopic dermatitis continues to have a massive impact worldwide, with patients not only burdened by intense itch and recurrent skin lesions, but also potentially several associated symptoms including sleep issues, pain, anxiety, and depression," said Professor Jonathan Silverberg, lead investigator of the ARCADIA program, in a news release. "I look forward to being able to offer this option to atopic dermatitis patients in my practice who are seeking relief from burdensome itch and lesions.”
Nemluvio was previously approved in August 2024 for prurigo nodularis and is currently under regulatory review for additional indications worldwide.
Source: Galderma press release. December 13, 2024.