Roche has received FDA approval for its antibody treatment Gazyva to be used in combination with standard therapy for adults with active lupus nephritis.
Lupus nephritis affects more than 1.7 million people worldwide — a disproportionate share of which are women. Left untreated, up to one-third of patients may progress to end-stage kidney disease,, according to an Oct. 19 news release from the company.
The drug, marketed as Gazyva in the U.S. and Gazyvaro in Europe, was already approved in 100 countries for hematological cancers. The FDA approval was based on late-stage trial results showing nearly half of patients receiving Gazyva in combination with standard therapy achieved a complete renal response, compared with 33.1% of patients who received standard treatment alone, according to an Oct. 20 news release.
Gazyva is administered intravenously — four doses in the first year, then twice annually. The FDA also approved a shorter 90-minute infusion time for eligible patients.
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