FDA approves Nemluvio for atopic dermatitis

Key takeaways:

• The approval was based on positive data from the phase 3 ARCADIA 1 and 2 clinical trials.
• The CHMP also issued positive recommendations for the drug in AD and prurigo nodularis.

The FDA has approved Nemluvio, in conjunction with topical corticosteroids and/or calcineurin inhibitors, for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older, Galderma announced in a press release.

A monoclonal antibody targeting IL-31 receptor alpha, Nemluvio (nemolizumab, Galderma) demonstrated a statistically significant reduction in itch in patients with AD in the phase 3 ARCADIA 1 and ARCADIA 2 trials, which evaluated Nemluvio’s efficacy compared with placebo in more than 1,700 patients.

Patients received subcutaneous Nemluvio or placebo in combination with topical corticosteroids or calcineurin inhibitors every 4 weeks for a total of 16 weeks.

EASI 75 was achieved by 44% and 42% of the patients in the respective treatment groups compared with 29% and 30% in the placebo groups. IGA scores of 0 or 1 were also achieved by 36% and 38% compared with 25% and 26%.

Jonathan I. Silverberg

“Nemluvio truly has a novel mechanism of action different than the other biologics that are approved for AD,which are all very similar mechanistically,” Jonathan I. Silverberg, MD, PhD, MPH, associate professor of medicine at George Washington University School of Medicine and Health Sciences and the lead investigator of the ARCADIA clinical program, told Healio. “We know that IL-31 plays a number of important roles in the disease, but it is particularly important with respect to the itch of atopic dermatitis. And, as we know, itch is the most burdensome symptom for patients and is really the symptom that drives our decision making more than anything else. So, I think the approval is a big deal for patients as well as providers as it gives us a new option.”

In addition to the FDA’s approval, the European Medicines Agency’s Committee for Medicinal Products for Human Use also issued a positive opinion of the drug for the treatment of atopic dermatitis and prurigo nodularis, recommending its approval for both indications.

The FDA previously approved Nemluvio for prurigo nodularis.

References:

• ARCADIA clinical trial program media factsheet. https://mms.businesswire.com/media/20241213562840/en/2332100/1/ARCADIA_Trial_Media_Factsheet_US_Approval_December_2024_FINAL.pdf?download=1. Published December 2024. Accessed Dec. 16, 2024.
• CHMP recommends approval of Galderma’s nemolizumab for moderate to severe atopic dermatitis and prurigo nodularis in the European Union. https://www.galderma.com/news/chmp-recommends-approval-galdermas-nemolizumab-moderate-severe-atopic-dermatitis-and-prurigo. Published Dec. 13, 2024. Accessed Dec. 16, 2024.