WEP Clinical LTD (WEP), a specialist services company that works with drug developers to help patients and physicians gain early access to medicines when no other treatment options are available, has partnered with biopharmaceutical company, Kiniksa Pharmaceuticals, Ltd. (Kiniksa), to launch a Named Patient Program (NPP) for ARCALYST, a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling.
The NPP designed to ensure that physicians outside the U.S. can request ARCALYST on behalf of individual patients who have recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), or deficiency of IL-1 receptor antagonist (DIRA) but reside in countries where ARCALYST is not currently commercially available.
Jas Khera, Managing Director of WEP Clinical, said:
“We are excited to partner with Kiniksa to help facilitate broader access to this much-needed therapeutic option. Kiniksa has already achieved some really great milestones with this product, and our team is looking forward to supporting the company’s goal of making ARCALYST available early to the patients in need around the world.”
For physicians who are interested in further information on the ARCALYST Named Patient Program, please contact: firstname.lastname@example.org.
About WEP Clinical
Established in 2008, WEP Clinical is a specialist services company that works with drug developers to help patients and physicians gain early access to medicines when no other treatment options are available. We have offices located in London, United Kingdom; RTP North Carolina, United States; Lisbon, Portugal; and Dublin, Ireland and possess all the necessary licenses allowing us to meet drug access and distribution needs across all regions, worldwide. We are passionate about helping those in need. For more information, please visit www.wepclinical.com.
Kiniksa Pharmaceuticals 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’s 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 www.kiniksa.com.
ARCALYST is a weekly, subcutaneously-injected recombinant dimeric fusion protein that blocks interleukin-1 alpha and interleukin-1 beta signaling. ARCALYST was discovered by Regeneron and is approved by the U.S. Food and Drug Administration (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. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2020.
About Recurrent Pericarditis
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.