FDA approves nemolizumab to treat atopic dermatitis in patients 12 years and up

FDA approves nemolizumab to treat atopic dermatitis in patients 12 years and upLatest revision | Image Credit: © Calin - © Calin - stock.adobe.com.

Nemolizumab (Nemluvio; Galderma) has been approved by the FDA to treat patients aged 12 years and up with moderate-to-severe atopic dermatitis in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI), when disease is not adequately controlled with topical prescription therapies, according to a press release from Galderma.

With the approval, nemolizumab becomes the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31, Galderma stated in a press release announcing the federal agency's decision. IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and epidermal dysregulation in atopic dermatitis.

Positive results demonstrated in the phase 3 ARCADIA clinical program led to the approval. The clinical program evaluated efficacy and safety of nemolizumab in combination with background TCs, with or without TCI, versus placebo, in 1728 patients aged 12 years or older with moderate-to-severe atopic dermatitis.

The ARCADIA 1 and 2 trials were global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials.

Those treated with nemolizumab, administered every 4 weeks in combination with TCS, with or without TCI, demonstrated statistically significant improvements on skin clearance by way of clearance (0) or almost-clearance (1) of skin lesions using the investigator's global assessment score. Improvement in another co-primary endpoint was also observed, with the achievement of a 75% reduction in the Eczema Area and Severity Index (EASI) compared to placebo in combination with TCS, with or without TCI, after 16 weeks of treatment.

Patients who responded to treatment and met the above primary endpoints, were re-randomized to a maintenance treatment phase for up to 48 weeks, according to the company.

"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," stated Jonathan Silverberg, MD, MPH, PhD, the lead investigator of the ARCADIA clinical program, and a professor of Dermatology at the George Washington University School of Medicine and Health Sciences, in a press 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," said Silverberg.

According to Galderma, nemolizumab was well tolerated and the safety profile was consistent between it and placebo groups during clinical trials. The trials met all key secondary endpoints, "confirming significant responses on itch as early as Week 1, and statistically significant improvements in sleep disturbance with Nemluvio in combination with TCS, with or without TCI, when compared to placebo in combination with TCS, with or without TCI," stated the company.

Those planning to receive nemolizumab should not receive a live vaccine right before or during treatment with nemolizumab. In additional, patients should speak to a health care provider if they:

• Are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby.

Reference:

Galderma receives US FDA approval for Nemluvia (nemolizumab) for patients with mdoerate-to-severe atopic dermatitis. Galderma. Press release. December 13, 2024. Accessed December 16, 2024. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic