Kiniksa Pharmaceuticals’ Rilonacept Receives Orphan Drug Designation for Pericarditis

The FDA has granted an Orphan Drug designation to Kiniksa Pharmaceuticals’ rilonacept for the treatment of pericarditis, an inflammation of the tissue surrounding the heart.  

Kiniksa licensed rilonacept from Regeneron Pharmaceuticals in 2017 for evaluation as a treatment for the condition. Regeneron currently markets the drug as Arcalyst for the treatment of Cryopyrin-associated periodic syndromes (CAPS), a rare hereditary inflammatory disorder.

Upon approval by the agency for pericarditis, Kiniksa will take over sales and distribution of the drug for all approved indications in the U.S.