FDA, EMA accept nemolizumab applications for prurigo nodularis, atopic dermatitis
Click Here to Manage Email Alerts
Key takeaways:
- The submission of nemolizumab for the treatment of prurigo nodularis was supported by data from the OLYMPIA program.
- The submission for atopic dermatitis was supported by the ARCADIA program.
The FDA and the European Medicines Agency have accepted applications for nemolizumab for the treatment of prurigo nodularis and moderate to severe atopic dermatitis in adolescents and adults, Galderma announced in a press release.
The FDA has accepted biologics license applications for the drug in each indication, whereas the European Medicines Agency has issued acceptance of the marketing authorization applications for both.
“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, MBA, global head of R&D at Galderma, said in the release. “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.”
Following its breakthrough designation in 2019 and 2023, nemolizumab, the first-in-class investigational monoclonal antibody specifically designed to inhibit interleukin-31 signaling, has been granted priority review by the FDA for the treatment of prurigo nodularis.
The regulatory submissions for prurigo nodularis were based on data from the phase 3 OLYMPIA clinical trial program, whereas the submission for atopic dermatitis was based on the ARCADIA program.
According to the press release, Galderma is planning for multiple regulatory submissions in 2024.
Editor's note: On Feb. 15, the lede was corrected to clarify that the approved indication's severity level for atopic dermatitis was moderate to severe. The editors regret the error.