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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