FDA Approves Kiniksa's Arcalyst for Recurrent Pericarditis

Kiniksa Pharmaceuticals has received FDA approval for Arcalyst (rilonacept), a once-weekly subcutaneous injection for treating recurrent pericarditis and reducing its risk of recurrence in adults and children age 12 years and older.

A recombinant-fusion protein, Arcalyst works by blocking interleukin-1 alpha and interleukin-1 beta signaling that cause inflammation leading to pericarditis, a swelling of the thin sac-like membrane encircling the heart.

Approval was supported by phase 3 trial results showing the drug had a 97 percent treatment response rate in enrollees, with patients seeing a 96 percent reduction in risk of a recurrent pericarditis event, and participants being pain-free or experiencing minimal pain 92 percent of the trial’s duration vs. 40 percent of trial days in the placebo group.

Kiniksa plans to commercially launch Arcalyst next month.