Kiniksa Pharmaceuticals: FDA Accepts Supplemental Application for Rilonacept for Pericarditis
By Chris Wack
Kiniksa Pharmaceuticals Ltd. said Monday the U.S. Food and Drug
Administration accepted the supplemental biologics license
application for rilonacept in recurrent pericarditis.
The biopharmaceutical company said the FDA granted priority
review to the application and assigned a Prescription Drug User Fee
Act goal date of March 21. Rilonacept is a weekly, subcutaneously
injected, recombinant dimeric fusion protein that blocks
interleukin-1 alpha and interleukin-1 beta signaling.
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
Rilonacept was discovered and developed by Regeneron
Pharmaceuticals Inc. and is approved by the FDA for the treatment
of cryopyrin-associated periodic syndromes. Kiniksa licensed
rilonacept from Regeneron in 2017. If approved by the FDA for
recurrent pericarditis, Kiniksa would take responsibility for sales
and distribution of rilonacept for all the approved indications in
the U.S. and evenly split profits with Regeneron.
Kiniksa is obligated to pay regulatory milestones to Regeneron
of up to $27.5 million through the time of a potential approval of
rilonacept in recurrent pericarditis, of which $7.5 million is
expected to be paid in the fourth quarter of 2020.
Kiniksa shares were up 7% to $15.80 in premarket trading.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires
November 23, 2020 08:49 ET (13:49 GMT)
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