March 18, 2021

The U.S. FDA has approved a new indication for Arcalyst® (rilonacept), manufactured by Kiniksa Pharmaceuticals, to treat recurrent pericarditis (RP) and reduce the risk of recurrence in patients who are at least 12 years old. Arcalyst is the first FDA-approved medication for recurrent pericarditis.

Pericarditis is inflammation of the pericardium, the layers of tissue that surround the heart to hold it in place and support proper function. Recurrent pericarditis is typically a complication of autoimmune disorders such as lupus or rheumatoid arthritis that cause the body’s immune system to attack healthy tissues. Pericarditis can be extremely painful and may feel like chest pain from a heart attack. It can also interfere with the heart’s function. In rare cases, it can be life-threatening.

In a clinical trial, 97% of patients responded to treatment with Arcalyst, with a 96% reduction in risk for a recurrent pericarditis event. The median time to treatment response was five days. Patients on Arcalyst also experienced either minimal or no pain for 92% of the trial days, compared to 40% of trial days for patients on placebo.

Under the new indication, Arcalyst has a recommended loading of 320mg for adults, administered as two 160mg subcutaneous (SC) injections. Maintenance dosing for adults is a single 160mg SC injection once weekly. For pediatric patients, the recommended loading dose is 4.4mg/kg of body weight, up to a maximum of 320mg, administered as one or two SC injections. Pediatric maintenance dosing is a single once-weekly SC injection of 2.2mg/kg, up to a maximum of 160mg. Arcalyst can be administered at home by a patient or caregiver.

First FDA approved in 2008, Arcalyst is also indicated to treat cryopyrin-associated periodic syndromes (CAPS) and to maintain remission of deficiency of interleukin-1 receptor antagonist (DIRA).

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