Genentech Gets FDA Breakthrough Designation for Gazyva in Lupus Nephritis

Date : 09/18/2019 @ 10:40AM
Source : Dow Jones News
Stock : Roche Holding (QX) (RHHBY)
Quote : 38.57  0.14 (0.36%) @ 9:11PM
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Genentech Gets FDA Breakthrough Designation for Gazyva in Lupus Nephritis

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By Colin Kellaher

 

Roche Holding AG's (ROG.EB) Genentech unit Wednesday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to Gazyva for adults with lupus nephritis, a potentially life-threatening inflammation of the kidneys.

Genentech said the designation is based on a phase II study in which Gazyva in combination with standard of care showed enhanced efficacy compared to placebo in achieving complete renal response at one year.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

There are currently no FDA-approved medicines for lupus nephritis, Genentech said.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

September 18, 2019 06:25 ET (10:25 GMT)

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

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