Kiniksa Gets FDA Orphan Designation for Rilonacept in Pericarditis

By Colin Kellaher

Kiniksa Pharmaceuticals Ltd. on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to rilonacept for the treatment of the autoinflammatory disease pericarditis, including recurrent pericarditis.

The Hamilton, Bermuda, biopharmaceutical company said it expects to file for FDA approval of the drug in recurrent pericarditis later this year, adding that it is actively preparing for commercialization.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

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.

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.

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

(END) Dow Jones Newswires

July 16, 2020 07:59 ET (11:59 GMT)

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