Galderma’s Nemluvio (Nemolizumab) Receives Positive CHMP Opinion to Treat Prurigo Nodularis (PN) and Atopic Dermatitis
Shots:
- The CHMP's recommendation of Nemluvio (SC) for mod. to sev. atopic dermatitis (≥12yrs.) & prurigo nodularis in eligible ones for systemic therapy was based on P-III ARCADIA & OLYMPIA studies, respectively. Reviews are ongoing in Australia, Singapore, Switzerland, Canada, Brazil & South Korea, with more filings underway
- ARCADIA 1 & 2 studies assessed Nemluvio (Q4W) + TCS ± TCI vs PBO in atopic dermatitis patients (n=1,728) for 16 & 48wks., respectively. It showed improved co-1EPs & 2EPs as well as itch relief at wk.1
- OLYMPIA1 & 2 trials assessed Nemluvio (Q4W) vs PBO in PN patients (n=560) for 16 & 24wks., respectively. It achieved its 1 & 2EPs, depicting improved itch & skin nodules at wk.16, with fast itch reductions at wk.4
Ref: Galderma| Image: Galderma
Related News:- Galderma’s Nemluvio (Nemolizumab) Secures the US FDA’s Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD)
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