By Colin Kellaher

 

Kiniksa Pharmaceuticals Ltd. on Monday said a pivotal phase 3 study of rilonacept in recurrent pericarditis met its primary and major secondary efficacy endpoints.

The Hamilton, Bermuda, biopharmaceutical company said rilonacept improved clinically meaningful outcomes associated with the unmet medical need in the autoinflammatory disease.

Kiniksa said it expects to submit a supplemental biologics license application to the U.S. Food and Drug Administration later this year. The FDA last year granted breakthrough-therapy designation to rilonacept for the treatment of recurrent pericarditis.

Rilonacept, which was discovered and developed by Regeneron Pharmaceuticals Inc., is approved by the FDA under the brand name Arcalyst for the treatment of cryopyrin-associated periodic syndromes. Under a 2017 licensing agreement with Regeneron, the biologic license application for that indication will transfer to Kiniksa.

If the FDA approves the drug in recurrent pericarditis, Kiniksa would assume the sales and distribution of rilonacept for approved indications in the U.S. and would evenly split profits on sales with Regeneron.

Trading in shares of Kiniksa was halted premarket on Monday.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

June 29, 2020 08:00 ET (12:00 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.
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