Posted by Michael Wonder on 23 Nov 2020
Kiniksa announces U.S. FDA acceptance of sBLA and priority review for rilonacept in recurrent pericarditis
23 November 2020 - Filing based on positive data from RHAPSODY, which achieved its primary and all major secondary endpoints.
Kiniksa Pharmaceuticals today announced that the U.S. FDA accepted the supplemental biologics license application for rilonacept in recurrent pericarditis.
The FDA granted priority review to the application and assigned a Prescription Drug User Fee Act goal date of 21 March 2021.
The FDA granted breakthrough therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019 and orphan drug designation to rilonacept for the treatment of pericarditis in 2020.
