{"id":469527,"date":"2021-04-01T08:03:21","date_gmt":"2021-04-01T12:03:21","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=469527"},"modified":"2021-04-01T08:03:21","modified_gmt":"2021-04-01T12:03:21","slug":"kiniksa-announces-commercial-availability-of-arcalyst-rilonacept-for-recurrent-pericarditis","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/kiniksa-announces-commercial-availability-of-arcalyst-rilonacept-for-recurrent-pericarditis\/","title":{"rendered":"Kiniksa Announces Commercial Availability of ARCALYST \u00ae (rilonacept) for Recurrent Pericarditis"},"content":{"rendered":"
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\n – ARCALYST is the first and only FDA-approved therapy for recurrent pericarditis \u2013<\/em>
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\n – ARCALYST now available on prescription basis in the U.S. \u2013<\/em>
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\n – Kiniksa One Connect\u2122 program provides ongoing patient access and support services \u2013 <\/em>\n <\/p>\n

HAMILTON, Bermuda, April 01, 2021 (GLOBE NEWSWIRE) — Kiniksa Pharmaceuticals, Ltd.<\/a> (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, today announced that ARCALYST \u00ae<\/em><\/sup> (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1\u03b1) and interleukin-1 beta (IL-1\u03b2) signaling, is now commercially available for recurrent pericarditis. On March 18, 2021, the U.S. Food and Drug Administration\u00a0(FDA) approved ARCALYST for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older.<\/p>\n

\u201cWe are excited to announce that ARCALYST is now available as the first and only approved therapy for patients with recurrent pericarditis,\u201d said Ross Moat, ARCALYST General Manager. \u201cOur experienced commercial and medical affairs teams have already begun to engage with physicians, payers and patients to raise awareness of this innovative treatment option. Kiniksa is committed to patient access and has established Kiniksa One Connect\u2122, our patient support program, which provides comprehensive access and support services for any patient prescribed ARCALYST.\u201d<\/p>\n

ARCALYST is available through a distribution network comprised of several specialty pharmacies, which provide extensive and timely access across the United States.<\/p>\n

Kiniksa One Connect\u2122 is available to assist patients on their treatment journey with ARCALYST. The program will help provide potential access, initiation, affordability solutions and ongoing patient support. For more information, call 1-833-KINIKSA (1-833-546-4572).<\/p>\n

ARCALYST was discovered and developed by Regeneron Pharmaceuticals, Inc. (Regeneron). Upon the approval by the FDA for recurrent pericarditis, Kiniksa took responsibility for sales and distribution of ARCALYST for all the approved indications in the United States, including cryopyrin-associated periodic syndromes (CAPS) and deficiency of IL-1 receptor antagonist (DIRA), and will evenly split profits with Regeneron, as described in the ARCALYST License Agreement.<\/p>\n

For more information on ARCALYST, visit www.arcalyst.com<\/a>.<\/p>\n

\n About Kiniksa<\/strong>
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Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa\u2019s portfolio of assets, ARCALYST, mavrilimumab, vixarelimab and KPL-404, are based on strong biologic rationale or validated mechanisms, target underserved conditions and offer the potential for differentiation. These assets are designed to modulate immunological pathways across a spectrum of diseases. For more information, please visit\u00a0www.kiniksa.com<\/a>.<\/p>\n

\n About Recurrent Pericarditis<\/strong>
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Recurrent pericarditis is a painful and debilitating 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 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.<\/p>\n

Kiniksa launched the RESONANCE Registry (REgiStry Of the NAtural of recurreNt periCarditis in pEdiatric and adult patients;\u00a0clinicaltrials.gov<\/a>:\u00a0NCT04687358<\/a>), a voluntary patient registry database led by physician-researchers with experience in managing patients with recurrent pericarditis, in March 2021. This registry aims to capture retrospective and prospective, longitudinal, observational data in up to 500 patients across the U.S. The continued advancement in recurrent pericarditis research underscores Kiniksa\u2019s commitment to partner with the healthcare and patient communities to improve the collective knowledge of this debilitating disease.<\/p>\n

\n About ARCALYST<\/strong>
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ARCALYST is a weekly, subcutaneously-injected recombinant dimeric fusion protein that blocks IL-1\u03b1 and IL-1\u03b2 signaling. ARCALYST was discovered by Regeneron and is approved by the FDA for recurrent pericarditis, CAPS, including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and DIRA. The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to ARCALYST for the treatment of pericarditis in 2020.<\/p>\n

\n About\u00a0the\u00a0ARCALYST License Agreement with Regeneron<\/strong>
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In 2017, Regeneron granted Kiniksa an exclusive license to develop and commercialize ARCALYST worldwide, excluding\u00a0Israel,\u00a0Egypt,\u00a0Turkey\u00a0and select countries in the\u00a0Middle East\u00a0and\u00a0North Africa. In\u00a0the United States\u00a0and\u00a0Japan, Kiniksa\u2019s license is for all indications other than those involving oncology and local administration to the eye or ear. Upon the approval of the supplemental Biologics License Application (sBLA) for ARCALYST in recurrent pericarditis, the scope of the license granted to Kiniksa expanded to include DIRA and CAPS in\u00a0the United States\u00a0and\u00a0Japan, and Kiniksa assumed the responsibility for sales and distribution of ARCALYST in these additional indications in the United States. Outside\u00a0the United States\u00a0and\u00a0Japan, Kiniksa\u2019s license is for all indications other than CAPS and certain periodic fever syndromes, DIRA, oncology, and local application to the eye or ear. Kiniksa and Regeneron will evenly split profits on sales of ARCALYST after deducting certain commercialization expenses, subject to specified limits.<\/p>\n

\n Important information about ARCALYST Injection<\/strong>\n <\/p>\n