Roche: FDA accepts request for approval

(CercleFinance.com) - Roche announced that the US FDA has accepted the company's supplemental new drug application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis.


Acceptance of the application is based on the positive results of the Phase III REGENCY study, which showed an improvement in complete renal response (CRR) with Gazyva/Gazyvaro combined with standard therapy compared with standard therapy alone. The FDA is expected to make a decision on approval by October 2025.

In people with lupus nephritis, Gazyva/Gazyvaro demonstrated a benefit in terms of complete renal response, a clinically meaningful outcome related to preservation of renal function and a slowing or prevention of end-stage renal disease, Roche's chief medical officer and head of global product development said.

The FDA's acceptance of the marketing authorisation application (sBLA) for Gazyva/Gazyvaro recognizes the need to provide a more effective treatment option for people living with this devastating disease.


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