dm+d

Unassigned

New Medicines

ArcalystRecurrent symptomatic pericarditis

Information

Arcalyst
New molecular entity
Kiniksa
Kiniksa

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Launched
Yes
Feb 22Hangzhou Zhongmei Huadong Pharmaceutical and Kiniska enter into a development and marketing agreement to develop and commercialise riilonacept in the Asia Pacific Region [11].
Mar 21FDA has approved rilonacept for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. The commercial launch is expected in April 2021 [8].
Jan 21Granted orphan drug status in EU for idiopathic pericarditis this will lead to recurrent pericarditis in many patients [9]
Nov 20Filed in US with priority review [7].
Jul 20Granted orphan drug status in US for treatment of pericarditis [5].

Category

Recombinant fusion protein that blocks IL-1α and IL-1β signaling
Recurrent pericarditis has a number of causes, including infective inflammatory and metabolic [2].
Recurrent symptomatic pericarditis
Subcutaneous injection

Trial or other data

Nov 20PIII RHAPSODY RCT (n=86) reports rilonacept led to rapid resolution of recurrent pericarditis episodes and to a significantly lower risk of pericarditis recurrence than placebo; 2 of 30 patients (7%) in rilonacept group had pericarditis recurrence vs. 23 of 31 patients (74%) in placebo group [6].
Jun 20Kiniksa announces positive data from PIII RHAPSODY trial (n=61). Median time to recurrence for patients on rilonacept, in withdrawal period, could not be estimated due to low number of recurrences vs.8.6 weeks for placebo recipients (HR0.04, p<0.0001) [4].