Galderma Reports the US FDA’s Approval of Nemluvio (Nemolizumab) for Treating Prurigo Nodularis (PN)
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
Click here to read the full press release
Tags
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.
