Company:
Type of Application: Supplemental biologics license application
Candidate: Rilonacept
Date: March 21
The sBLA for rilonacept was accepted for priority review by the FDA in November, with a PDUFA goal date of March 21. Rilonacept is a weekly, subcutaneously-injected recombinant dimeric fusion protein that blocks interleukin-1 alpha and interlukin-1 beta signaling.
It was discovered by
Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and is approved by the FDA under the brand name Arcalyst for the treatment of cryopyrin-associated periodic syndromes, specifically familial cold autoinflammatory syndrome and Muckle-Wells Syndrome, and DIRA. Kiniksa licensed rilonacept from Regeneron in 2017.
If approved by the FDA for recurrent pericarditis, Kiniksa will take responsibility for sales and distribution of rilonacept for all the approved indications in the U.S. and evenly split profits with Regeneron.