By Elena Vardon 
 

AstraZeneca said Monday that a phase four trial for its Andexxa drug for patients experiencing intracranial haemorrhage will be stopped early after it achieved prespecified criteria showing an ability to limit the expansion of potentially life-threatening brain bleeding.

The Anglo-Swedish pharma giant said the decision was taken by the independent data and safety monitoring board after an assessment of efficacy with 450 patients who had been randomized and followed for one month.

The company will now begin the closure of the trial and go ahead with regulatory filings in the U.S. and the European Union to convert it from conditional to full label approval.

 

Write to Elena Vardon at elena.vardon@wsj.com

 

(END) Dow Jones Newswires

June 05, 2023 02:41 ET (06:41 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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