Shots:
- The approval of Nemluvio (SC pre-filled pen) was based on P-III (OLYMPIA 1 & 2) studies assessing its safety & efficacy vs PBO in PN patients (n= >500)
- Studies met their 1 & 2EPs, showing at least a 4-point reduced itch intensity in 56% & 49% vs 16% (both PBO groups); skin nodules clearance in 26% & 38% vs 7% & 11% and at least a 4-point reduced sleep disturbance in 50% & 52% vs 12% & 21% at wk.16. At least a 4-point reduced itch intensity in 41% (both studies) vs 6% & 7% was seen at wk.4
- The US FDA is reviewing its BLA for moderate-to-severe AD, with a decision expected in H2’24; MAA in PN & AD are also under review in the EU, Canada, Australia, Singapore, Switzerland & the UK, with further submissions planned in 2024
Ref: Galderma | Image: Galderma| Press Release
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