Nemolizumab filings for prurigo nodularis, atopic dermatitis accepted in four countries
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Key takeaways:
- Regulatory authorities in four countries have accepted nemolizumab filings indicated for prurigo nodularis and atopic dermatitis.
- Submissions were supported by the OLYMPIA and ARCADIA clinical trial programs.
Galderma has received filing acceptances for nemolizumab for the treatment of prurigo nodularis and atopic dermatitis in Australia, Singapore, Switzerland and the United Kingdom, the company announced in a press release.
The four countries, whose regulatory authorities are members of the Access Consortium, accepted the nemolizumab filings for the treatment of patients with prurigo nodularis and adults and adolescents with moderate to severe atopic dermatitis. According to the release, Galderma expects an approval from the Access Consortium next year.
“These four new filing acceptances once again reinforce the potential blockbuster status of nemolizumab, which has shown great promise in both prurigo nodularis and atopic dermatitis,” Baldo Scassellati Sforzolini, MD, PhD, MBA, global head of R&D at Galderma, said in the release. “With even more filings anticipated this year, we are looking forward to finally bringing this long-awaited therapy to patients with these serious conditions as soon as possible, given the high burden of disease they still face.”
The acceptance of nemolizumab in prurigo nodularis was based on data from the phase 3 OLYMPIA clinical trial program, whereas the acceptance of the drug in atopic dermatitis was based on data from the phase 3 ARCADIA clinical trial program.
Nemolizumab has received many filing acceptances from regulatory agencies recently, including from the FDA and European Medicines Agency in February 2024. The drug also received breakthrough therapy designation from the FDA in December 2019 for the treatment of pruritus associated with prurigo nodularis, which was reconfirmed in March 2023.
According to the release, further submissions to regulatory authorities in additional countries are ongoing.
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