Alexion Gets FDA Priority Review of Ultomiris in Kidney Disorder
June 20 2019 - 9:00AM
Dow Jones News
By Colin Kellaher
Alexion Pharmaceuticals Inc. (ALXN) Thursday said the U.S. Food
and Drug Administration accepted for priority review its
supplemental biologics-license application for Ultomiris in
atypical hemolytic uremic syndrome, a rare disease that causes
abnormal blood clots to form in small blood vessels in the
kidneys.
The Boston biopharmaceutical company said the agency set a
target action date of Oct. 19.
The FDA grants priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review period to
six months from the standard 10 months.
The FDA late last year approved Ultomiris for adults with the
rare and life-threatening blood disease paroxysmal nocturnal
hemoglobinuria.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 20, 2019 08:45 ET (12:45 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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