Vanda Pharmaceuticals' Imsidolimab FDA Filing Accepted, Target Date December 12

Vanda Pharmaceuticals announced that the FDA has accepted the filing of its Biologics License Application, or BLA, for imsidolimab for the treatment of Generalized Pustular Psoriasis, or GPP, with a target action date of December 12. 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, or 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. 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 at Week 4 compared to 13% on placebo. If imsidolimab is approved, it will be the third new drug product approved for Vanda in the past 12 months, following NEREUS and BYSANTI.