Kiniksa (KNSA) Announces FDA Approval of ARCALYST for Recurrent Pericarditis

March 18, 2021 4:33 PM EDT
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Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, today announced the U.S. Food and Drug Administration (FDA) approved ARCALYST ® (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling, for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. The commercial launch is expected in April 2021.

“The approval of ARCALYST in recurrent pericarditis offers patients the first and only FDA-approved therapy for this devastating disease and also represents a transformational event for Kiniksa,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “I would like to thank the recurrent pericarditis community and specifically acknowledge the exceedingly dedicated patients, nurses, physicians and caregivers who participated in the clinical trials as well as the Kiniksa team whose absolute focus on patients made this possible. We look forward to launching ARCALYST for recurrent pericarditis with the support of our experienced commercial and medical affairs teams and, importantly, providing this breakthrough therapy to patients suffering with this debilitating disease as quickly as possible.”

Recurrent pericarditis is a painful autoinflammatory cardiovascular disease that typically presents with chest pain and is often associated with changes in electrical conduction and sometimes buildup of fluid around the heart, called pericardial effusion. Patients who have additional pericarditis episodes following a symptom-free period of 4-6 weeks or longer are identified as having recurrent pericarditis. Recurrent pericarditis symptoms have an impact on quality of life, limit physical activities, and lead to frequent emergency department visits and hospitalizations. Data show that approximately 40,000 patients in the U.S. seek and receive treatment for recurrent pericarditis each year. Of that group, approximately 14,000 patients experience a second or subsequent event (recurrence) due to persistent underlying disease or inadequate response to conventional therapies, such as nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine and corticosteroids.

The FDA approval of ARCALYST in recurrent pericarditis follows positive data from RHAPSODY, a pivotal Phase 3 trial of ARCALYST in recurrent pericarditis. RHAPSODY met its prespecified primary endpoint of time-to-first adjudicated pericarditis recurrence in the randomized withdrawal period and all major secondary efficacy endpoints with statistical significance. The data showed that ARCALYST treatment in the trial improved clinically meaningful outcomes associated with the significant unmet medical need in recurrent pericarditis. There were rapid and sustained reductions in both reported pain and inflammation as early as after the first dose. Median time to treatment response was 5 days, with a 97% treatment response rate. Patients randomized to ARCALYST experienced a 96% reduction in the risk for a recurrent pericarditis event (Hazard Ratio = 0.04, p<0.0001), with 92% of trial days being pain free or at most experiencing minimal pain, compared to 40% of trial days on placebo (p<0.0001). The most common adverse events were injection site reactions and upper respiratory tract infections. RHAPSODY data were published in The New England Journal of Medicine simultaneously with a late-breaking scientific presentation at the American Heart Association’s Scientific Sessions 2020.

“Recurrent pericarditis is a debilitating disease that disrupts the lives of afflicted patients. Data have shown that recurrent pericarditis stems from an underlying autoinflammatory pathophysiology mediated by IL-1α and IL-1β,” said Allan Klein, MD, of Cleveland Clinic, co-principal investigator of RHAPSODY and compensated member of a 2019 Kiniksa scientific advisory committee. “This approval supports the concept of a targeted immunomodulation therapeutic strategy as a paradigm shift in the management of patients with this devastating disease.”

Kiniksa is providing Kiniksa One Connect™, a program that will assist patients on their treatment journey. The program will help provide access, initiation, affordability solutions and ongoing support for any patient receiving ARCALYST therapy. For more information, call 1-833-KINIKSA (1-833-546-4572).

“The approval of ARCALYST in recurrent pericarditis is an extremely important achievement for those suffering from this disease as there can be significant impact on a patient’s physical and emotional health as well as quality of life,” said Dona Winnowski, President of the Pericarditis Alliance. “The development and commercialization of new medicines for underserved and severe diseases are essential, and this first FDA-approved therapy in recurrent pericarditis brings hope to patients and their families.”

ARCALYST was discovered by Regeneron Pharmaceuticals, Inc. (Regeneron) and received initial FDA approval in February 2008 for the treatment of cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and subsequent approval for the maintenance of remission of deficiency of IL-1 receptor antagonist (DIRA) in December 2020.

Kiniksa licensed ARCALYST from Regeneron in 2017 for evaluation in diseases believed to be mediated by both IL-1α and IL-1β, including recurrent pericarditis. Upon this approval by the FDA for recurrent pericarditis, Kiniksa takes responsibility for sales and distribution of ARCALYST for all the approved indications in the United States, including CAPS and DIRA, and will evenly split profits with Regeneron, as described in the ARCALYST License Agreement.

For more information on ARCALYST, visit

Conference Call InformationKiniksa will host a conference call and webcast at 5:30 p.m. Eastern Time on Thursday, March 18, 2021 to discuss the FDA approval of ARCALYST for recurrent pericarditis. Individuals interested in participating in the call should dial (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 2458467. To access the webcast, please visit the Investors and Media section of Kiniksa’s website at The archived webcast will be available on Kiniksa’s website for 14 days beginning approximately one hour after the call has completed.

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