FDA Accepts Galderma’s BLA for Nemolizumab for the Treatment of Prurigo Nodularis and Atopic Dermatitis

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Galderma recently announced that the FDA has accepted its biologics license application (BLA) for nemolizumab for the treatment of prurigo nodularis and adolescents and adults with moderate to severe atopic dermatitis. The FDA has also granted nemolizumab Priority Review for prurigo nodularis. Previously, the FDA granted nemolizumab Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis in December 2019.

Nemolizumab is a first-in-class investigational monoclonal antibody specifically designed to inhibit IL-31 signaling to provide safe and rapid relief from itch.

The regulatory submissions of nemolizumab in prurigo nodularis are based on data from the phase 3 OLYMPIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every 4 weeks in patients with prurigo nodularis.

“Because this patient population has suffered for a long time, anytime there's a hope of new therapeutics, it's very exciting for doctors and for patients; nemolizumab has the potential to be a very significant addition to our armamentarium against treating itch,” said Shawn Kwatra, MD, in a previous interview with Dermatology Times discussing the latest phase 3 OLYMPIA 2 data of nemolizumab for prurigo nodularis published in the New England Journal of Medicine.

In the OLYMPIA program, patients treated with nemolizumab monotherapy showed clinically and statistically significant improvements in both primary end points compared to placebo after 16 weeks of treatment. More than half of patients treated with nemolizumab achieved at least a 4-point reduction in itch intensity, as measured by the Peak-Pruritus Numerical Rating Scale (PP-NRS; 58% and 56% in OLYMPIA 1 and 2, respectively, compared to 17% and 21% in the placebo groups; p<0.0001). Additionally, one-third of patients treated with nemolizumab reached clearance or almost-clearance of skin lesions when assessed using Investigator’s Global Assessment (IGA) scores (26% and 38% in OLYMPIA 1 and 2, respectively, compared to 7% and 11% in the placebo groups; p<0.0001).

Regarding key secondary end points, 41% of patients treated with nemolizumab achieved at least a 4-point reduction in itch in both the OLYMPIA 1 and 2 studies, as measured by the PP-NRS score, compared to 6% and 8% in the placebo groups (p<0.0001), respectively.

The phase 3 OLYMPIA clinical trial program is currently the largest clinical trial program investigating prurigo nodularis, with more than 500 patients enrolled, and the only one to include a long-term extension study.

The regulatory submissions of nemolizumab in atopic dermatitis are based on data from the phase 3 ARCADIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every 4 weeks in adolescents and adults with moderate to severe atopic dermatitis. Both ARCADIA trials showed clinically and statistically significant improvements in co-primary end points, compared to placebo, after 16 weeks of treatment.

More than one-third of patients treated with nemolizumab reached clearance or almost-clearance of skin lesions when assessed using IGA scores (36% and 38% in ARCADIA 1 and 2, respectively, compared to 25% and 26% in the placebo groups; p<0.001). Additionally, more than 40% of patients treated with nemolizumab achieved a 75% reduction in the Eczema Area and Severity Index (44% and 42% in ARCADIA 1 and 2, respectively, compared to 29% and 30% in the placebo groups; p<0.001).

For the secondary end points, almost half of patients treated with nemolizumab achieved at least a 4-point reduction in itch intensity as measured by the PP-NRS score (49% and 48% in ARCADIA 1 and 2, respectively, compared to 21% in the placebo groups; p<0.0001, MI-MAR analysis).

“The relentless itch experienced by many people living with prurigo nodularis and atopic dermatitis has a significant impact on their overall quality of life. We are thankful to the patients and medical experts whose insights informed our clinical trials, which assessed nemolizumab’s ability to reduce the symptoms of itch and skin lesions. We are one step closer to delivering this innovative solution to those in need and look forward to the outcomes of these filing decisions,” said Baldo Scassellati Sforzolini, MD, PhD, the global head of research and development at Galderma, in the news release.

Reference

Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU. News release. Galderma. February 14, 2024. Accessed February 14, 2024. https://www.galderma.com/news/galderma-announces-regulatory-filing-acceptance-nemolizumab-prurigo-nodularis-and-atopic