The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to rilonacept (Kiniksa Pharmaceuticals) for the treatment of recurrent pericarditis. 

Rilonacept is a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin (IL)-1α and IL-1β signalling. The Agency based their decision on data from an open-label phase 2 trial, which included 25 patients with recurrent pericarditis. Results showed that treatment with rilonacept was associated with a reduction in recurrences of pericarditis episodes (from 3.9 episodes/year prior to study to <0.18 episodes/year), as well as improvements in both patient-reported outcomes and other clinical manifestations of pericarditis.  

The Company is currently enrolling patients in a phase 3 trial (RHAPSODY) to assess the efficacy and safety of rilonacept vs placebo; the primary end point of the study is time to pericarditis recurrence in the 24-week randomized withdrawal period. Top-line results are expected in the second half of 2020. 

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Rilonacept is currently approved by the FDA under the brand name Arcalyst for the treatment of cryopyrin-associated periodic syndromes, including familial cold autoinflammatory syndrome and Muckle-Wells syndrome.

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