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Vanda Pharmaceuticals Submitted An FDA Biologics License Application For Imsidolimab For Generalized Pustular Psoriasis

Benzinga · 3d ago
  • Vanda has requested priority review for the BLA, citing GPP's status as a rare orphan disease with significant unmet need. If granted, priority review would establish a six-month review cycle, with a potential FDA approval of imsidolimab for the treatment of GPP as early as mid-2026.
  • The BLA is supported by positive results from the global Phase 3 GEMINI-1 and GEMINI-2 studies, where a single intravenous dose of imsidolimab led to rapid disease clearance, achieving clear or almost clear skin, with efficacy maintained throughout an approximately 2-year maintenance study period with monthly doses. Imsidolimab demonstrated a favorable safety profile with no clinically meaningful safety signals.