Kiniksa Pharmaceuticals Gets Orphan Drug Designation for KPL-387
By Chris Wack
Kiniksa Pharmaceuticals International said the Food and Drug Administration has granted orphan drug designation to KPL-387 for the treatment of pericarditis, which includes recurrent pericarditis.
The biopharmaceutical 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.
Kiniksa said KPL-387 could provide an additional treatment option for patients by potentially enabling dosing with a single monthly subcutaneous self-injection in a liquid formulation.
The FDA grants orphan drug designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. Orphan drug designation entitles a party to financial incentives such as opportunities for grant funding toward clinical trial costs, tax advantages and user-fee waivers.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 17, 2025 08:42 ET (12:42 GMT)
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