Kiniksa Announces U.S. FDA Acceptance of sBLA and Priority Review for Rilonacept in Recurrent Pericarditis

- PDUFA goal date of March 21, 2021 -
- Filing based on positive data from RHAPSODY, which achieved its primary and all major secondary endpoints -
- Rilonacept BLA for CAPS transferred to Kiniksa from Regeneron -

HAMILTON, Bermuda, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for rilonacept in 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. Rilonacept is a weekly, subcutaneously-injected, recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. The FDA granted Breakthrough Therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for the treatment of pericarditis in 2020.

The regulatory submission was based on positive data from RHAPSODY, a pivotal Phase 3 trial of rilonacept in recurrent pericarditis. RHAPSODY met its prespecified primary and all major secondary efficacy endpoints, showing that rilonacept treatment in the trial improved clinically meaningful outcomes associated with the significant unmet medical need in recurrent pericarditis. RHAPSODY data were recently published in The New England Journal of Medicine simultaneously with a late-breaking scientific presentation at the American Heart Association’s Scientific Sessions 2020.

“We are thrilled to receive the FDA’s acceptance of the sBLA submission for rilonacept in recurrent pericarditis with priority review, said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “Rilonacept has the potential to become the first FDA-approved therapy for this painful and debilitating autoinflammatory disease. We are committed to bringing this potential treatment option to patients as soon as possible.”

Rilonacept was discovered and developed by Regeneron Pharmaceuticals, Inc. (Regeneron) and is approved by the FDA for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) under the brand name ARCALYST. 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 RHAPSODY data, the Biologic License Application (BLA) for CAPS transferred to Kiniksa. 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, as described in the Rilonacept License Agreement.