FDA Approves New IL-31 Drug for Eczema

The FDA approved nemolizumab (Nemluvio) in combination with prescription topical agents for the treatment of moderate-to-severe atopic dermatitis, drugmaker Galderma announced.

A monoclonal antibody that targets interleukin (IL)-31 receptor alpha, nemolizumab is specifically indicated for individuals 12 years and older with eczema that is not sufficiently controlled with topical corticosteroids and/or calcineurin inhibitors.

Nemolizumab is delivered via subcutaneous injection and was approved earlier this year for treating prurigo nodularis in adults.

Two identical phase III trials — ARCADIA 1 and ARCADIA 2 — supported the atopic dermatitis approval. Participants in both had moderate-to-severe atopic dermatitis that was inadequately controlled on prescription topicals. They remained on their background therapy and received either nemolizumab or placebo every 4 weeks.

“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 ARCADIA investigator Jonathan Silverberg, MD, PhD, MPH, of George Washington University School of Medicine and Health Sciences in Washington, D.C.

Both studies met their co-primary endpoints. A significantly higher proportion of nemolizumab-treated participants achieved scores of 0 or 1 (clear or almost clear) on the investigator’s global assessment score at week 16:

• ARCADIA 1: 36% vs 25% with placebo (P=0.0003)
• ARCADIA 2: 38% vs 26% (P=0.0006)

And more patients assigned to nemolizumab had a 75% reduction on the Eczema Area and Severity Index at week 16 as well:

• ARCADIA 1: 44% vs 29% (P
• ARCADIA 2: 42% vs 30% (P=0.0006)

The two trials also met all key secondary endpoints, including significant itch relief as early as week 1 and reductions in sleep disturbance.

“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,” said Silverberg.

Common adverse events with nemolizumab in the trials included headache, joint pain, hives, and muscle aches. Hypersensitivity reactions have been reported with the drug, and the warnings and precautions section of the prescribing information recommend that patients do not receive live vaccines while on nemolizumab.