Kiniksa Pharmaceuticals Says FDA Grants Orphan Drug Designation For KPL-387 To Treat Pericarditis

(RTTNews) - Biopharmaceutical company Kiniksa Pharmaceuticals International, plc (KNSA) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis, which includes recurrent pericarditis.

KPL-387 is an independently developed monoclonal antibody that binds human interleukin-1 receptor 1, inhibiting the signaling activity of the cytokines interleukin-1a and interleukin-1ß.

The company said data from the Phase 2 dose-focusing portion of the KPL-387 Phase 2/3 recurrent pericarditis trial are expected in the second half of 2026.