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