FDA Puts Partial Hold on AbbVie's Venetoclax Clinical Trials for Multiple Myeloma

Date : 03/19/2019 @ 2:04PM
Source : Dow Jones News
Stock : Roche Holding (QX) (RHHBY)
Quote : 37.53  0.19 (0.51%) @ 9:38PM

FDA Puts Partial Hold on AbbVie's Venetoclax Clinical Trials for Multiple Myeloma

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By Allison Prang


The U.S. Food and Drug Administration has put a partial clinical hold on AbbVie Inc.'s (ABBV) clinical trials for using venetoclax for multiple myeloma, the company said.

AbbVie said the FDA's move comes after the company's Phase 3 Bellini trial saw more deaths from the arm of the trial using venetoclax when compared with the trial's controlled arm.

AbbVie said "no new patients should be enrolled in any studies of venetoclax for multiple myeloma until a further analysis of the data is completed."

The company said the FDA's partial hold doesn't affect indications for which venetoclax has already been approved.

AbbVie is developing venetoclax with Roche Holding AG.


Write to Allison Prang at allison.prang@wsj.com


(END) Dow Jones Newswires

March 19, 2019 09:49 ET (13:49 GMT)

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

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