Posted by Michael Wonder on 17 Dec 2025
Vanda announces submission of biologics license application to the FDA for imsidolimab for the treatment of generalised pustular psoriasis
15 December 2025 - Vanda Pharmaceuticals today announced the submission of a biologics license application to the US FDA) for imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalised pustular psoriasis.
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 biologics license application 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.
