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The FDA has accepted the Biologics License Application (BLA) for imsidolimab, a monoclonal antibody that inhibits interleukin (IL)-36 receptor signaling, as a treatment of generalized pustular psoriasis (GPP), the manufacturer, Vanda Pharmaceuticals, announced in a press release.
GPP is a rare, chronic disorder, which is increasingly linked to genetic variants in the IL36RN gene “encoding the IL-36 receptor antagonist,” according to the release. In 2022, another IL-36 receptor antagonist, spesolimab (Spevigo), was approved for treating GPP flares in adults, the first FDA-approved therapy for GPP. In 2024, it was approved for an expanded indication, the treatment of GPP in adults and pediatric patients aged 12 or older.
The filing was supported by global studies known as GEMINI-1 and GEMINI-2; results were published in an abstract in the Journal of Investigative Dermatology in 2025. In these studies, 53% of patients with GPP achieved clear or almost clear skin at 4 weeks after a single intravenous dose of imsidolimab compared with 13% of patients on placebo based on scores of 0/1 on the GPP Physician Global Assessment scale.
With monthly doses, imsidolimab showed sustained efficacy over a maintenance period of approximately 2 years and no flares were reported in treated patients, according to the company release, and treatment was associated with a low incidence of antidrug antibodies.
The target action date for the application is December 12, 2026, according to Vanda.
