DJ FDA clears Roche’s Gazyva for treatment of lupus nephritis
By Billy Gray
DOW JONES–Roche has received FDA approval for its drug Gazyva for the treatment of lupus nephritis in adults who are currently receiving standard therapy for this autoimmune disease that targets the kidneys.
The Swiss pharmaceutical company announced on Monday that the FDA had also approved a shortened waiting time between infusions of 90 minutes for eligible patients. After taking four doses in the first year of treatment, the drug can be administered twice a year, potentially making the treatment more convenient compared to standard therapy, the statement added.
The approval was based on study results in a late phase and was based on the improved effectiveness of the drug compared to standard treatment alone, said Roche. The drug – sold under the name Gazyvaro in the European Union and Switzerland and under the name Gazyva in the United States and the rest of the world – is the only drug of its kind proven to help patients with lupus nephritis regain full kidney function, the company said.
Nearly half of patients in the clinical trial who took the drug in combination with standard treatment had a complete kidney response, compared with 33.1 percent among patients who received standard treatment alone, according to Roche.
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(END) Dow Jones Newswires
October 20, 2025 02:38 ET (06:38 GMT)
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