Shots:
- The FDA has received Vanda’s BLA for imsidolimab to treat GPP, with a priority review requested that could enable potential approval as early as mid-2026
- BLA was supported by global P-III (GEMINI-1 & 2) trials, where GEMINI-1 (n=45) evaluated a single IV dose of imsidolimab (300 or 750mg) vs PBO, & GEMINI-2 re-randomized pts to 200mg monthly SC maintenance dosing vs PBO for ~116wks.
- Trials showed rapid & durable efficacy, with 53% achieving clear or almost clear skin (GPPGA 0/1) at Wk. 4 vs 13% on single dose, & all pts on active maintenance remaining flare-free with sustained skin clearance for ~2yrs., compared with 25% maintenance & 63% flares
Ref: PR Newswire | Image: Vanda | Press Release
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