- 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-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