Imsidolimab

Feb. 25, 2026 -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026. 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. The pathogenesis of GPP is increasingly understood through its genetic characterization (OMIM #614204), and its molecular etiology is mainly attributed to excessive activity of the interleukin-36 (IL-36) pathway.1 The majority of GPP cases for which a causal single gene defect has been identified are caused by various consequential genetic variants in the IL36RN gene, encoding the IL-36 receptor antagonist (IL-36Ra).2,3,4 Imsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is believed to achieve its therapeutic effects in GPP where IL-36 signaling is unbalanced. If approved, imsidolimab could address a significant unmet medical need in this rare and life-threatening disorder with potential benefits over currently existing treatments. Imsidolimab was studied in global clinical studies conducted in the United States, France, Spain, Poland, Turkey, Malaysia, Thailand, Georgia, Tunisia, Taiwan, and Morocco. In the pivotal efficacy studies GEMINI-1 and GEMINI-2, a single intravenous dose of imsidolimab led to rapid disease clearance, with 53% of patients achieving clear or almost clear skin (GPPPGA 0/1) at Week 4 compared to 13% on placebo. Efficacy was maintained throughout an approximately 2-year maintenance period with monthly doses, and no flares occurred in the active treatment arm. Imsidolimab exhibited a favorable safety profile and demonstrated a low incidence of anti-drug antibodies, which can be a significant advantage over existing treatments. GPP is a rare disorder with prevalence estimates varying widely by region, ranging from approximately 2 to 124 cases per million worldwide (lower in Europe and higher in parts of Asia).5,6 "The acceptance of the BLA filing for imsidolimab marks a critical milestone in our efforts to bring this innovative therapy to patients suffering from GPP," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "Imsidolimab builds on our growing expertise in rare orphan disorders and our anti-inflammatory portfolio. Imsidolimab represents a precision medicine approach targeting a disorder with a known genetic cause using a fully humanized monoclonal antibody against the IL-36 receptor. We look forward to potential FDA approval and leveraging our commercial infrastructure to address this debilitating condition." Vanda celebrates this significant milestone for imsidolimab's acceptance for review by the FDA during Rare Disease Week on Capitol Hill (February 24–26, 2026), as advocates unite to promote innovation and access to treatments for rare orphan diseases like generalized pustular psoriasis. If imsidolimab is approved, it will be the third new drug product approved for Vanda in the past 12 months, following NEREUS™ (tradipitant) and BYSANTI™ (milsaperidone). References Online Mendelian Inheritance in Man, OMIM®. Johns Hopkins University, Baltimore, MD. MIM Number: 614204: 12/16/2020. Available at: https://omim.org/ Marrakchi, S. et al. Interleukin-36–Receptor Antagonist Deficiency and Generalized Pustular Psoriasis. New England Journal of Medicine 365, 620–628 (2011). Sugiura, K. et al. The Majority of Generalized Pustular Psoriasis without Psoriasis Vulgaris Is Caused by Deficiency of Interleukin-36 Receptor Antagonist. Journal of Investigative Dermatology 133, 2514–2521 (2013). Johnston, A. et al. IL-1 and IL-36 are dominant cytokines in generalized pustular psoriasis. Journal of Allergy and Clinical Immunology 140(1), 109–120 (2017). Sachen, K. L. et al. Role of IL-36 cytokines in psoriasis and other inflammatory skin conditions. Cytokine 156, 155897 (2022). Prinz, J. C. et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. Journal of the European Academy of Dermatology and Venereology 37, 256–273 (2022). Imsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is being developed for GPP, a rare orphan indication. Regulatory and patent exclusivity for imsidolimab is expected to extend into the late 2030s. Vanda holds an exclusive global license for the development and commercialization of imsidolimab from AnaptysBio (Nasdaq: ANAB). Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. The content above comes from the network. if any infringement, please contact us to modify.