Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
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.
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.
For more information visit Kiniksa.com.
This article originally appeared on MPR
