Genentech Gets FDA Breakthrough Designation for Gazyva in Lupus Nephritis
September 18 2019 - 6:40AM
Dow Jones News
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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