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Vanda Announces Submission of Biologics License Application to the FDA for Imsidolimab for the Treatment of Generalized Pustular Psoriasis
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today 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.
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[{"type":"text","content":"WASHINGTON, Dec. 15, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today 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.","length":488,"tagName":"p"},{"type":"image","alt":"Vanda Logo (PRNewsfoto/Vanda Pharmaceuticals Inc.)","displaySize":"","headline":null,"caption":"Vanda Logo (PRNewsfoto/Vanda Pharmaceuticals Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":260,"url":"https://media.zenfs.com/en/prnewswire.com/743d2f4492e0b465012535111f8b6bc6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/t6bNuh3kAr03Rxr6Kla3dQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQ1ODtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/743d2f4492e0b465012535111f8b6bc6","width":400,"height":260}},"href":"https://mma.prnewswire.com/media/2090054/VandaLogo_v1.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"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.","length":415,"tagName":"p"},{"type":"text","content":"GPP is a rare, chronic, life-threatening autoinflammatory skin disorder characterized by sudden flares of widespread pustules, erythema, and systemic symptoms such as fever and fatigue. Driven primarily by loss-of-function mutations in IL36RN, GPP represents a significant unmet medical need, with prevalence estimates varying widely by region, ranging from approximately 2 to 124 cases per million worldwide (e.g., lower in Europe and higher in parts of Asia).1,2,3,4","length":468,"tagName":"p"},{"type":"text","content":""The submission of the BLA for imsidolimab marks a critical milestone in our efforts to bring this innovative therapy to patients suffering from GPP...