AstraZeneca Says Ultomiris Accepted by FDA for Priority Review
21 Dezembro 2021 - 04:49AM
Dow Jones News
By Anthony O. Goriainoff
AstraZeneca PLC said Tuesday that its Ultomiris drug has been
accepted by the U.S. Food and Drug Administration for priority
review for adults with generalized myasthenia gravis, known as
gMG.
The London-listed drug giant said the supplemental Biologics
License Application for Ultomiris was based on a positive phase 3
trial where the drug significantly improved functional
activities.
The company said gMG is a rare autoimmune neuromuscular disease
that is characterized by severe muscle weakness.
The biopharmaceutical company said the FDA has set a
Prescription Drug User Fee Act date for the second quarter of
2022.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
December 21, 2021 02:34 ET (07:34 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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