Kiniksa Gets FDA Orphan Designation for Rilonacept in Pericarditis
July 16 2020 - 8:14AM
Dow Jones News
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)
Copyright (c) 2020 Dow Jones & Company, Inc.
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