Recurrent pericarditis (RP) is a painful and debilitating autoinflammatory cardiovascular disease.
Inhibitor of interleukin-1α (IL-1α) and interleukin-1β (IL-1β), cytokines that have been shown to play a key role in inflammatory diseases.
Health plan claims analysis (cross-validated with published estimates) supports that there are approximately 40,000 patients with RP in the United States seeking and receiving medical treatment for RP.
Orphan Drug designation granted by the US Food and Drug Administration (FDA) for rilonacept for the treatment of pericarditis.
Breakthrough Therapy designation granted by the US Food and Drug Administration (FDA) for rilonacept for the treatment of recurrent pericarditis.
We reported data from RHAPSODY, a global, randomized withdrawal (RW) design, pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis in June 2020. RHAPSODY met its prespecified primary and all major secondary efficacy endpoints.
Rilonacept was discovered and developed by Regeneron Pharmaceuticals, Inc. (Regeneron) and is approved by the FDA under the brand name ARCALYST® for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). Kiniksa licensed rilonacept from Regeneron in 2017 for evaluation in diseases believed to be mediated by both IL-1α and IL-1β, including recurrent pericarditis. Based on positive Phase 3 RHAPSODY data, the Biologic License Application (BLA) for CAPS will transfer to Kiniksa, and the company plans to submit a Supplemental Biologic License Application (sBLA) with the FDA in recurrent pericarditis by the end of 2020. Upon receipt of FDA approval for rilonacept in recurrent pericarditis, Kiniksa would assume the sales and distribution of rilonacept for the approved indications in the United States and will evenly split profits on sales with Regeneron.
We are not aware of any current therapies approved by the FDA for the treatment of RP.