EIRs/483s

Priority Review for Gazyva sBLA for Primary Membranous Nephropathy

FDA has granted Roche a priority review for its supplemental BLA seeking approval for Gazyva (obinutuzumab) for treating adults with primary membranous nephropathy (pMN), potentially positioning the anti-CD20 antibody as the first FDA-approved therapy for the rare autoimmune kidney disease. The agency is expected to complete its review by November, the company says.

The filing is supported by data from the Phase 3 MAJESTY trial, which demonstrated that Gazyva significantly outperformed the immunosuppressant tacrolimus in achieving complete remission after two years of treatment.

According to Roche, 36.9% of patients treated with Gazyva achieved complete remission at 104 weeks compared with 5.7% of patients receiving tacrolimus. The study also met key secondary endpoints, including higher rates of overall remission and earlier complete remission. No new safety signals were identified, and the drug's safety profile was consistent with previous studies.

Primary membranous nephropathy is described as a chronic autoimmune disease in which antibodies attack the kidney's filtering units, leading to protein leakage into the urine and progressive kidney damage. Although some patients experience spontaneous remission, up to 30% can progress to kidney failure within a decade if left untreated.

The Priority Review marks the second recent expedited FDA review for Gazyva in kidney disease. In May, the agency granted priority review for the drug in idiopathic nephrotic syndrome, another immune-mediated kidney disorder.

Gazyva is already approved for treating adults with active lupus nephritis, based on results from the Phase 3 REGENCY study and earlier NOBILITY trial, the company says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome