U.S. FDA grants Kiniksa's rilonacept breakthrough therapy

today, Kiniksa Pharmaceuticals(http://announced that the U.SFDA(http://granted its determination to treat recurrent enticatis (RP) in the il-1 signaling pathway inhibitor rilonaceptAbout Rilonacept
Rilonacept is a soluble fusion protein injected with subcutaneous injection, with the ligand binding domain of the extracellular part of IL-1 receptor 1 (IL-1R1), and IL-1 receptor assisted protein (IL-1RAcP), linearly connected to the Fc binding domain of human immunoglobulin G1 (IgG1)It suppresses IL-1 signaling by acting as a receptor that binds to IL-1 alpha and IL-1 beta, thus blocking their interaction with the IL-1 receptor on the cell surfaceRilonacept was discovered and developed by Regeneron, and Kiniksa further developed treatments for RP patients with its exclusive permissionThe determination of this breakthrough therapy is based on positive results obtained by rilonacept in a Phase 2 clinicaltrial(http://The results showed that during the six-month treatment period, the incidence of heart encased in patients treated with rilonacept decreased from 3.9 times per year to less than 0.18 per year compared to the patient's natural historyIn addition, rilonacept enables rapid improvement in the clinical performance of cardioclonitis in RP patients with pain-related quality of life (QoL), as well as C-reactive protein (CRP) levels, cardiac fluid, and changes in heart activityIn terms of safety
in subgroups of patients with (http:// of CS
drugs, patients received rilonacept treatment without recurrence of peributytis and were not treated with CS drugs during this period 　　The positive data from this trial supports Kiniksa's continuation of the key Phase 3 clinical trial of rilonacept treatment RP