Roche announced today that Gazyva/Gazyvaro (obinutuzumab) has been approved by the U.S. Food and Drug Administration (FDA) to treat adult patients with active lupus nephritis. For patients with this serious kidney complication of lupus, a chronic autoimmune disease, this represents a major breakthrough.
Women of colour are disproportionately affected by lupus nephritis, which can result in end-stage kidney disease. Gazyva/Gazyvaro’s approval presents a novel therapeutic option that has proven to be more effective than the current standard of care.
Positive results from two important clinical trials the Phase II NOBILITY study and the Phase III REGENCY study formed the basis of the FDA’s decision. Nearly half of the participants who received Gazyva/Gazyvaro in combination with standard therapy experienced a complete renal response, according to the REGENCY study, which was especially compelling. Only a third of patients who only received standard therapy, on the other hand, accomplished this goal.
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.
Levi Garraway
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Gazyva/Gazyvaro showed better overall disease control in addition to the improved renal response. The drug’s safety profile aligned with its established profile in hematology-oncology, where it is currently utilised. The only anti-CD20 monoclonal antibody to demonstrate such a notable benefit in a Phase III study for lupus nephritis is Gazyva/Gazyvaro.
The course of treatment for Gazyva/Gazyvaro consists of twice-yearly infusions after four initial doses in the first year. Patients may find this less frequent dosing schedule to be a more practical choice. Roche is also looking into Gazyva/Gazyvaro’s potential for other kidney-related conditions.
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Lupus nephritis is a dangerous and frequently incapacitating illness. With a more effective and possibly more manageable treatment path, this FDA approval gives patients and their families hope.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
