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KINIKSA Kiniksa Announces FDA Approval of ARCALYST ® ( rilonacept ) for Recurrent Pericarditis March 18 , 2021 - ARCALYST is the first and only FDA - approved therapy for recurrent pericarditis - - Commercial launch expected in April 2021 - - Kiniksa launches Kiniksa One Connect ™ patient support program - - Conference call and webcast scheduled for 5:30 p.m. EDT today - HAMILTON , Bermuda , March 18 , 2021 ( GLOBE NEWSWIRE ) -- 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 - 1a ) and interleukin - 1 beta ( IL - 1ẞ ) 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 - 1a and IL - 1ẞ , " 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 - 1a and IL - 1ẞ , 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 .