Shots:
- The US FDA has approved Nemluvio + TCS ± calcineurin inhibitors (TCI) to treat mod. to sev. atopic dermatitis in patients unresponsive to topical therapies
- Approval was based on the P-III (ARCADIA) study of the combination vs PBO in patients (n=1,728; ≥12yrs.), showing significant skin clearance in both co-1EPs of IGA score (0/1) & 75% EASI reduction at wk.16.; 2EPs of itch relief & improved sleep disturbance, were also met
- Nemluvio has received the CHMP’s positive opinion in Dec 2024 for AD & prurigo nodularis. Submissions in Australia, Singapore, Switzerland, Canada, Brazil & South Korea are under review, with more expected in 2025
Ref: Galderma | Image: Galderma | Press Release
Related News:- Checkpoint Therapeutics’ Unloxcyt (Cosibelimab-ipdl) Receives the US FDA’s Approval for Cutaneous Squamous Cell Carcinoma (cSCC)
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