By Oliver Griffin 
 

AstraZeneca PLC (AZN.LN) said Friday that pooled cardiovascular safety analyses of its global phase 3 program for roxadustat has produced top-line results.

The pharmaceutical company said the pooled results will inform discussions with regulatory authorities concerning roxadustat, which is used to treat anemia in patients with chronic kidney disease.

AstraZeneca and FibroGen Inc. (FGEN), the treatment's originator, will now conduct talks with the U.S. Food and Drug Administration to prepare for regulatory submission.

Roxadustat is expected to be submitted for regulatory approval in the second half of this year.

 

Write to Oliver Griffin at oliver.griffin@dowjones.com; @OliGGriffin

 

(END) Dow Jones Newswires

May 10, 2019 02:29 ET (06:29 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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