Vanda Pharmaceuticals announces submission of BLA to FDA for imsidolimab

Vanda Pharmaceuticals (VNDA) announced the submission of a Biologics License Application, BLA, to the U.S. Food and Drug Administration, FDA, for imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis, GPP. Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36RA regulator commonly seen in GPP patients due to IL36RN gene mutations. 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. 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.