Earlier today, Kiniksa announced an update on rilonacept, an investigational therapy in development for the treatment of recurrent pericarditis. Kiniksa announced positive data from RHAPSODY, a pivotal Phase 3 trial of rilonacept. RHAPSODY met its prespecified primary and all major secondary efficacy endpoints. Rilonacept was well-tolerated in the study, with adverse events consistent with the FDA-approved label for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). The most common adverse events were injection site reactions.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019, and Kiniksa intends to submit these data to the FDA as part of a Supplemental Biologics License Application (sBLA) later this year.
Please click below to read the press release.
Congratulations to the scientists at Kiniksa for their work on Recurrent Pericarditis!