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Galderma Reports US FDA and EMA Filing Acceptances for Nemolizumab to Treat Prurigo Nodularis and Atopic Dermatitis; US FDA grants Priority Review in Prurigo Nodularis

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Galderma Reports US FDA and EMA Filing Acceptances for Nemolizumab to Treat Prurigo Nodularis and Atopic Dermatitis; US FDA grants Priority Review in Prurigo Nodularis

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  • The BLA was supported by two P-III (OLYMPIA & ARCADIA) programs of nemolizumab (SC, Q4W) vs PBO for treating patients with prurigo nodularis as well as adolescents & adults with moderate to severe atopic dermatitis, respectively
  • The OLYMPIA study results revealed that >50% of patients attained at least 4-point reduced itch intensity and ~33% achieved clearance/almost-clearance of skin lesions in 16wks. The trial also met the 2EPs incl. quick onset of action on itch and sleep disturbance within 4wks.
  • The ARCADIA trial results showed that >33% achieved clearance/almost-clearance of skin lesions while >40% attained a 75% reduced Eczema Area & Severity Index after 16wks. The study also met the 2EPs same as in the OLYMPIA study at 16wks.

Ref: Galderma | Image: Galderma

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Shivani Chandra

Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.

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