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Kiniksa Pharmaceuticals Says Pericarditis Treatment Candidate Got US FDA Orphan Drug Designation
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Kiniksa Pharmaceuticals Says Pericarditis Treatment Candidate Got US FDA Orphan Drug Designation
Oct 17, 2025 6:23 AM

08:58 AM EDT, 10/17/2025 (MT Newswires) -- Kiniksa Pharmaceuticals International ( KNSA ) said Friday that its KPL-387 antibody has received Orphan Drug Designation from the US Food and Drug Administration for the treatment of pericarditis.

The company said data from the mid-stage dose-focusing portion of its KPL-387 phase 2/3 recurrent pericarditis study will be available in H2 of next year.

KPL-387 is an investigational, fully human immunoglobulin IgG2 monoclonal antibody that binds human interleukin-1 receptor 1, or IL-1R1, inhibiting the signaling of the IL-1alpha and IL-1beta cytokines, the company said.

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