The US Food and Drug Administration (FDA) has granted approval for Roche’s Gazyva/ Gazyvaro (obinutuzumab) to treat adult patients with active lupus nephritis (LN) who are on standard therapy.
The approval allows for a reduced infusion time of 90 minutes after the initial infusion for those who are eligible. After four initial doses in the first year, Gazyva can be administered biannually.
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Roche chief medical officer and global product development head Levi Garraway stated: “People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease.
“The approval of Gazyva/Gazyvaro by the FDA marks an important step towards a potential new standard of care for lupus nephritis, one that could allow clinicians to offer their patients more effective disease control.”
The approval is grounded in the findings of the Phase II NOBILITY and Phase III REGENCY clinical trials.
Data revealed that 46.4% of participants receiving Gazyva in conjunction with standard therapy attained a complete renal response, in contrast to 33.1% of those on standard therapy alone.
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By GlobalDataThis was further supported by enhancements in complement levels, reductions in lowered proteinuria, anti-double-stranded DNA (dsDNA) and decreased corticosteroid usage.
Lupus nephritis affects more than 1.7 million individuals globally, with a disproportionate impact on women, particularly women of childbearing age and those of colour.
If left untreated, as many as one-third of those affected may progress to end-stage kidney disease, which frequently necessitates dialysis or a kidney transplant.
Gazyva received the FDA’s breakthrough therapy designation in 2019. The Committee for Medicinal Products for Human Use of the European Medicines Agency ihas ssued a positive opinion recommending its approval, with a final decision from the European Commission anticipated shortly.
