Genentech’s Gazyva® Accepted for Review by FDA for Treatment of Lupus Nephritis
South San Francisco, CA – Genentech, a leading biotechnology company and a member of the Roche Group, recently announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of lupus nephritis. This filing acceptance comes on the heels of positive results from the Phase III REGENCY study, which demonstrated improved complete renal response (CRR) with Gazyva plus standard therapy compared to standard therapy alone.
Improved Outcomes for Lupus Nephritis Patients
Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), a chronic autoimmune disease. It affects the kidneys and can lead to irreversible damage if left untreated. The REGENCY study enrolled 387 patients with active lupus nephritis and randomized them to receive either Gazyva plus standard therapy or standard therapy alone. The study met its primary endpoint, with a significantly higher percentage of patients achieving CRR in the Gazyva arm (52.8%) compared to the standard therapy arm (34.8%).
What Does This Mean for Patients?
For those living with lupus nephritis, the acceptance of the sBLA for Gazyva is a promising development. Improved treatment options can mean better outcomes and a higher quality of life. However, it’s important to note that this is just the first step in the approval process. The FDA will now review the data from the REGENCY study and make a final decision on whether to approve Gazyva for the treatment of lupus nephritis.
Global Impact of Gazyva for Lupus Nephritis
Beyond the United States, Genentech is also pursuing regulatory approvals for Gazyva in other countries. The European Medicines Agency (EMA) has already granted a priority review for the marketing authorization application for Gazyva in the European Union for the treatment of adult patients with lupus nephritis. If approved, this would expand treatment options for patients in Europe as well.
Conclusion
The acceptance of the sBLA for Gazyva by the FDA marks an important step forward in the treatment of lupus nephritis. The positive results from the REGENCY study suggest that Gazyva could offer improved outcomes for patients, making it a potentially game-changing development for those living with this chronic and debilitating disease. However, the approval process is ongoing, and it will be some time before we know for sure whether Gazyva will become a standard treatment option. In the meantime, those living with lupus nephritis can take heart in the progress being made in the field and the promise of new, more effective treatments on the horizon.
- Genentech announces FDA acceptance of sBLA for Gazyva in lupus nephritis treatment
- Phase III REGENCY study shows improved CRR with Gazyva plus standard therapy
- FDA review ongoing, EMA grants priority review for EU marketing authorization
- Potential for improved outcomes and expanded treatment options for lupus nephritis patients
