Recurrent pericarditis (RP) is a painful and debilitating autoinflammatory cardiovascular disease.
Inhibitor of interleukin-1α (IL-1α) and interleukin-1β (IL-1β).
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 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. The Biologic License Application (BLA) for CAPS transferred to Kiniksa, and the FDA accepted the supplemental Biologic License Application (sBLA) for recurrent pericarditis. The FDA granted priority review to the application and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 21, 2021. If approved by the FDA for recurrent pericarditis, Kiniksa will take responsibility for sales and distribution of rilonacept for all the approved indications in the United States and evenly split profits with Regeneron.
We are not aware of any current therapies approved by the FDA for the treatment of RP.