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 2020.

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 [e-mail]

(END) Dow Jones Newswires

November 23, 2020 08:49 ET (13:49 GMT)

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