Galderma’s Nemluvio (Nemolizumab) Secures the US FDA’s Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD)
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
Related News:- Galderma Publishes the P-III (OLYMPIA 1) Trial of Nemolizumab for Prurigo Nodularis in JAMA Dermatology
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
