FDA approves Kiniksa’s recurrent pericardis treatment ARCALYST
pharmafile | March 22, 2021 | News story | Sales and Marketing | FDA
The FDA have approved ARCALYST (rilonacept) for the treatment and risk reduction of recurrent pericardis in adults and children over the age of 12.
The FDA’s approval follows positive data of ARCALYST in recurrent pericardis, and is seeking to be launched commercially next month. It becomes the first and only FDA-approved therapy for the disease.
Recurrent pericardis is a cardiovascular disease that typically causes chest pain. It is associated with changes in electrical conduction and sometimes a buildup of fluid around the heart, which is called pericardial effusion. Patients that continue to have episodes after a symptom-free period of time greater than four weeks are considered to have recurrent pericardis.
Around 40,000 patients in the US alone receive treatment for recurrent pericarditis each year, and approximately 14,000 of those patients experience a second or subsequent event due to a persistent underlying disease or an inadequate response to conventional therapies.
Kiniksa’s weekly, subcutaneously-injected, recombinant fusion protein blocks interleukin-1 alpha and interleukin-1 beta signalling, and achieved a 97% treatment response rate in its Phase III trial. Rapid and sustained reductions in pain and inflammation were reported as early as after the first dose in the Phase III, double-blind, placebo-controlled study RHAPSODY.
Sanj K Patel, Chief Executive Officer and Chairman of the Board at Kiniksa, said: “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.”
In addition to the launch of ARCELYST, Kiniksa are also providing a treatment programme to assist patients throughout their treatment journey. Kiniksa One Connect will provide access, initiation, affordability solutions, and ongoing support for anyone receiving the ARCALYST therapy.
Will Brown
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