Kiniksa sBLA for Rilonacept in Recurrent Pericarditis

FDA has accepted for priority review a Kiniksa Pharmaceuticals supplemental BLA for rilonacept in recurrent pericarditis. Rilonacept is a weekly, subcutaneously-injected, recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. Recurrent pericarditis is a painful and debilitating autoinflammatory cardiovascular disease that typically presents with chest pain and is associated with changes in electrical conduction and sometimes buildup of fluid around the heart, called pericardial effusion. The submission was based on positive data from the Phase 3 RHAPSODY trial that showed “rilonacept improved clinically meaningful outcomes associated with the significant unmet medical need in recurrent pericarditis,” according to the company. Rilonacept is currently FDA-approved for treating Cryopyrin-associated Periodic Syndromes. The agency set a user fee review action date of 3/21/2021.