FDA grants Roche's Vinutuzumab breakthrough drug for lupus nephritis

Roche, thegiant ofPharmaceuticals(http:// in Switzerland, recently announced that theAuthority for food anddrugshttp://
(http:// has granted Gazyva (obinutuzumab, obituzumab) a breakthrough drug qualification (BTD) for treating adult patients with lupus nephritisThis BTD grant is based on phase II NOBILITY (NCT05250652)The study was a randomized, double-blind, placebo-controlled, multicenter Phase II study in a group of 126 adult patients identified as type III or IV hyperactivity lupus nephritis based on the International Society of Nephrology/Rentopathology Society (ISN/RPS) lupus nephritis phase standard (2003)The study assessed the efficacy and safety of Gazyva and placebo in a joint standard care program (McCophenolic acid (MMF) or McCorphenolic acid (MPA), combined corticosteroids) respectivelyIn the study, patients were randomly assigned to Receive Gazyva or placebo infusions on days 1, 15, 168, and 182The primary endpoint is the proportion of patients who reached the program-defined full renal remission (CRR) at week 52 of treatmentThe results showed that the study reached a major endpoint: in the 52nd week of treatment, when combined with the standard care program (MMF or MPA, combined corticosteroids), a higher proportion of patients in the Gazyva group reached CRR than the placebo groupCompared to the placebo group, the Gazyva group showed improvements in overall renal remission (full and partial renal remission) and serological markers of disease activity, reaching a critical secondary endpoint of the study