– Educational campaign to raise awareness of recurrent pericarditis and to empower patients to discuss ARCALYST with their healthcare provider –
– Media accompanying this announcement is available by clicking on
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LONDON, April 08, 2026 (GLOBE NEWSWIRE) — Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today announced the launch of Heart’s Home™, a Direct-to-Consumer (DTC) campaign for ARCALYST, the first-and-only U.S. Food and Drug Administration (FDA) approved therapy for recurrent pericarditis. This multi-faceted campaign is aimed at identifying, educating, and empowering patients living with recurrent pericarditis to discuss ARCALYST with their healthcare provider.
“Each year, approximately 40,000 patients in the U.S. are impacted by debilitating recurrent pericarditis flares. Greater awareness and proactive treatment remain critical first steps to taking back control with a long-term strategy that addresses the underlying disease and protects patients from repeated, unnecessary flares,” said Ross Moat, Chief Operating Officer of Kiniksa. “This targeted campaign provides a clear call-to-action for patients with recurrent pericarditis to ask their doctor about the potential to prevent repeated flares while on ARCALYST.”
“Since launching ARCALYST in recurrent pericarditis, we have continued to deliver this transformative therapy to a growing number of patients, with sustained IL-1 pathway inhibition increasingly recognized as the preferred second line treatment approach,” said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “Alongside our commercial infrastructure, our highly targeted approach with Heart’s Home reflects Kiniksa’s ongoing data-driven efforts to efficiently reach additional patients not currently accessing this important treatment.”
Heart’s Home highlights the disruptive impact of recurrent pericarditis, empowering patients living with this disease to talk to their healthcare provider about ARCALYST, a long-term strategy to treat recurrent pericarditis and reduce the risk of future flares.
The educational campaign is currently live on connected TV devices and streaming channels and will also include digital and social media components. The full connected TV ad can be viewed by visiting www.arcalyst.com.
ARCALYST is the first-and-only FDA approved therapy for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. ARCALYST is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling.
See IMPORTANT SAFETY INFORMATION about ARCALYST below.
For more information on ARCALYST, visit www.arcalyst.com.
About Recurrent Pericarditis
Recurrent pericarditis is a painful and debilitating chronic autoinflammatory cardiovascular disease marked by inflammation of the pericardium and is often associated with changes in electrical conduction and sometimes buildup of fluid around the heart, called pericardial effusion. 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 two or more recurrences due to persistent underlying disease or inadequate response to conventional therapies, such as nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, and corticosteroids.
About Kiniksa
Kiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa’s portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit www.kiniksa.com.
About ARCALYST
ARCALYST is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. ARCALYST was discovered by Regeneron Pharmaceuticals, Inc. (Regeneron) and is approved by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older. ARCALYST is also approved by the FDA for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older, and the maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more. The FDA granted Orphan Drug Exclusivity to ARCALYST upon its approval for recurrent pericarditis in 2021. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021.
IMPORTANT SAFETY INFORMATION ABOUT ARCALYST
- ARCALYST may affect your immune system and can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in patients taking ARCALYST. If you have any signs of an infection, call your doctor right away. Treatment with ARCALYST should be stopped if you get a serious infection. You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection).
- While taking ARCALYST, do not take other medicines that block interleukin-1, such as Kineret® (anakinra), or medicines that block tumor necrosis factor, such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), as this may increase your risk of getting a serious infection.
- Talk with your doctor about your vaccine history. Ask your doctor whether you should receive any vaccines before you begin treatment with ARCALYST.
- Medicines that affect the immune system may increase the risk of getting cancer.
- Stop taking ARCALYST and call your doctor or get emergency care right away if you have any symptoms of an allergic reaction.
- Your doctor will do blood tests to check for changes in your blood cholesterol and triglycerides.
- Common side effects include injection-site reactions (which may include pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site), upper respiratory tract infections, joint and muscle aches, rash, ear infection, sore throat, and runny nose.
For more information about ARCALYST, talk to your doctor and see the
Product Information
.
Forward-Looking Statements
This press release contains forward-looking statements. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: the expected results of our DTC campaign, such as identifying, educating and empowering patients living with recurrent pericarditis to discuss ARCALYST with their healthcare provider; our believe that ARCALYST is a long-term strategy to treat recurrent pericarditis and reduce the risk of future flares; our beliefs about the mechanisms of our assets and potential impact of their approach; statements regarding our belief about the future of our commercial opportunities; and our belief that our portfolio of assets offers the potential for differentiation.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: complications in coordinating requirements, regulations and guidelines of regulatory authorities; potential undesirable side effects caused by our products and product candidates; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; raw material, important ancillary product and drug substance and/or drug product shortages; existing or new competition; current and future healthcare reforms, including those affecting the delivery of or payment for healthcare products and services; and the impact of global events such as changes in economic policy, uncertainty in national and international markets, conflict, terrorism and war.
These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
ARCALYST® is a registered trademark of Regeneron Pharmaceuticals, Inc.
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Kiniksa Investor & Media Contact
Jonathan Kirshenbaum
(781) 829-3949
[email protected]
