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


(END) Dow Jones Newswires

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

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