Biologics License Application for Nemolizumab Accepted by FDA for Prurigo Nodularis, Atopic Dermatitis

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In addition to the newly-accepted BLA in the US, the European Medicines Agency also accepted the drug’s Marketing Authorization Application for both conditions.

Both the US Food and Drug Administration (FDA) and the European Medicines Agency accepted the Biologics License Applications and Marketing Authorization Applications, respectively, of nemolizumab treatment for prurigo nodularis and adults and adolescents with atopic dermatitis.1

This announcement by Galderma concerning the acceptance of regulatory filing for the drug in its treatment of both conditions follows the success of the drug in the phase 3 OLYMPIA and ARCADIA trials. Notably, the FDA granted nemolizumab Priority Review for its use among patients with prurigo nodularis.

Nemolizumab, a first-in-class investigational monoclonal antibody formulated to address pruritis among prurigo patients by inhibiting IL-31 signaling, had been labeled a Breakthrough Therapy for the treatment of itch linked to prurigo nodularis in 2019 and 2023.2

“The relentless itch experienced by many people living with prurigo nodularis and atopic dermatitis has a significant impact on their overall quality of life,” Baldo Scassellati Sforzolini, MD, PhD, Galderma’s global head of R&D said in a statement. “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.”1

These submissions to both the FDA and the European Medicines Agency were preceded by efficacy and safety findings from the OLYMPIA clinical trials for prurigo nodularis and the ARCADIA clinical trials for atopic dermatitis.1

In OLYMPIA, 16-week treatment with nemolizumab as a monotherapy was shown to have cleared skin nodules among patients, rapidly improved itch, and diminished sleep disturbances, demonstrating improvements deemed statistically significant for both of the investigators’ primary endpoints compared to placebo.

An itch intensity reduction of at least 4 points had been observed among 58% and 56% of of those in the treatment group for OLYMPIA 1 and 2, respectively, as determined by the peak-pruritus numerical rating scale (PP-NRS). This differed from the same reductions seen in only 17% and 21% in the placebo arms of the same trials (P < 0.0001).

Additionally, those in the treatment arm for both trials saw, on average, clearance or almost-clearance of their lesions, as determined by their score on the investigator’s global assessment (IGA). Specifically, the participants saw rates of 26% and 38% in OLYMPIA 1 and 2, respectively, compared to 7% and 11% among those given a placebo (P < 0.0001).
In both of the OLYMPIA trial programs, the subjects also were shown by the investigators to have met all of their key secondary endpoints.

In the phase 3 ARCADIA clinical trial program, the investigators had looked at subcutaneous nemolizumab administration given every 4 weeks to adolescent and adult patients known to have moderate to severe atopic dermatitis. The research team found that statistically-significant skin lesion improvements and rapid itch and sleep disturbance improvements were also observed after 16 weeks.

Specifically, the ARCADIA investigators had shown that 36% of those in ARCADIA 1 and 38% of those in ARCADIA 2 were able to get clearance or almost clearance on their IGA scores, as opposed to 25% and 26% in the placebo arms of both trials, respectively (P < 0.001). Additionally, 44% and 42% of those in the treatment arms of ARCADIA 1 and 2 had a 75% Eczema Area and Severity Index score reduction, respectively, as opposed to 29% and 30% in the placebo arms (P < 0.001).

Both trials also were shown by the team to have met each of their key secondary endpoints as well. Overall, the drug was shown in both the ARCADIA and OLYMPIA trial programs to have been generally well tolerated, with its safety profile shown to be similar to placebo in both trials.

“We are one step closer to delivering this innovative solution to those in need and look forward to the outcomes of these filing decisions,” Sforzolini concluded.

References

  1. Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU. Galderma. February 14, 2024. https://www.galderma.com/news/galderma-announces-regulatory-filing-acceptance-nemolizumab-prurigo-nodularis-and-atopic. Date accessed: February 14, 2024.
  2. A Butera. Nemolizumab Reduces Itch, Improves Skin Lesions of Patients with Prurigo Nodularis. HCPLive. July 3, 2022. https://www.hcplive.com/view/nemolizumab-reduces-itch-skin-lesions-prurigo-nodularis. Date accessed: February 14, 2024.
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