Roche Holding (QX) (USOTC:RHHBY)
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3 Months : From Sep 2019 to Dec 2019
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.
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(END) Dow Jones Newswires
September 18, 2019 06:25 ET (10:25 GMT)
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