Tacrolimus

Roche announced Monday that a Phase III study of Gazyva/Gazyvaro (obinutuzumab) in adults with primary membranous nephropathy met its primary endpoint, potentially setting up another approval for the anti-CD20 monoclonal antibody and the first for a therapy in this chronic autoimmune condition. The MAJESTY trial randomised 142 people with primary membranous nephropathy to receive Gazyva/Gazyvaro or tacrolimus. Results showed that significantly more people achieved complete remission at week 104 with Gazyva/Gazyvaro versus tacrolimus, meeting the study's main goal. Analysis of key secondary endpoints also showed statistically significant and clinically meaningful benefits with Gazyva/Gazyvaro versus tacrolimus in overall remission at week 104 and complete remission at week 76. "These results demonstrate that Gazyva/Gazyvaro may help more people with primary membranous nephropathy achieve complete remission, maintain kidney function for longer and delay or potentially prevent the onset of life-threatening complications," said Levi Garraway, Roche's head of global product development. The company noted that safety was in line with the Gazyva/Gazyvaro's profile and no new safety signals were identified. Data are set to be presented at an upcoming medical meeting and shared with health authorities including the FDA and EMA. As well as being approved for various types of haematological cancers, Gazyva/Gazyvaro gained clearance at the end of last year in the US and EU for adults with active lupus nephritis. The therapy has also achieved positive Phase III study results in systemic lupus erythematosus and idiopathic nephrotic syndrome. The content above comes from the network. if any infringement, please contact us to modify.

– MAJESTY, the first global Phase III study in primary membranous nephropathy, met its primary endpoint of complete remission at two years – – Up to 30% of people with membranous nephropathy progress to kidney failure over 10 years despite current treatment approaches; achieving complete remission can help delay or prevent this – – Gazyva could become the first approved treatment for primary membranous nephropathy, having already achieved positive results in lupus nephritis, systemic lupus erythematosus and idiopathic nephrotic syndrome – – Gazyva is a glycoengineered, anti-CD20 monoclonal antibody designed to achieve deep tissue B cell depletion – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, showing statistically significant and clinically meaningful results with Gazyva ® (obinutuzumab). Results show that significantly more people achieved complete remission at two years (104 weeks) with Gazyva versus tacrolimus. Safety was in line with the well-characterized pro Gazyva and no new safety signals were identified. “These results demonstrate that Gazyva may help more people with primary membranous nephropathy achieve complete remission, maintain kidney function for longer and delay or potentially prevent the onset of life-threatening complications,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “If approved, Gazyva would be the first therapy specifically indicated for people with primary membranous nephropathy, where there are limited treatment options.” Analysis of key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva versus tacrolimus in overall remission (complete or partial remission) at week 104 and complete remission at week 76. Data will be presented at an upcoming medical meeting and shared with health authorities including the U.S. Food and Drug Administration and the European Medicines Agency. Primary membranous nephropathy is a chronic autoimmune condition that causes potentially irreversible kidney damage and reduced kidney function, and it is estimated that it affects over 96,000 people in the U.S. Up to 30% of people with primary membranous nephropathy will develop kidney failure over 10 years, which requires invasive intervention like dialysis or transplant and has a significant impact on patients and their families, as well as carrying substantial cost to health systems. Gazyva has the potential to address this by targeting an underlying cause of the condition, which may help maintain kidney function for longer and prevent the onset of life-threatening complications. MAJESTY is the fourth positive Phase III study of Gazyva in immune-mediated diseases, following REGENCY in lupus nephritis, ALLEGORY in systemic lupus erythematosus and INShore in idiopathic nephrotic syndrome. This growing body of evidence supports Gazyva's potential in addressing disease activity across a spectrum of immune-mediated diseases. Gazyva is approved in the U.S. and European Union for the treatment of adults with active lupus nephritis based on data from the REGENCY and NOBILITY studies and is being investigated in a global Phase II study of children and adolescents with lupus nephritis. Beyond Gazyva, we have a broad pipeline as part of our ambition to be leaders in immunology, in particular in immune-mediated and kidney-related diseases. Gazyva ® (obinutuzumab) is a humanized monoclonal antibody designed with a Type II anti-CD20 region, for direct B cell death and a glycoengineered Fc region, for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC). CD20 is a protein found on certain types of B cells. Gazyva is approved for adults with lupus nephritis in the US and EU. Gazyva is also approved in 100 countries for various types of hematological cancers. MAJESTY [NCT04629248] is a Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of Gazyva ® (obinutuzumab) in people with primary membranous nephropathy. The study enrolled 142 people who were randomized 1:1 to receive Gazyva or tacrolimus. The primary endpoint is the percentage of people who achieve complete remission at two years (week 104). Primary membranous nephropathy is a chronic autoimmune condition where the body’s immune system attacks the filtering units of the kidney, the glomeruli, causing protein to leak into the urine and potentially a gradual decline in kidney function. Over time, the damage to the kidneys can become irreversible, increasing the risk of life-threatening complications, such as kidney failure, idiopathic nephrotic syndrome, blood clots and cardiovascular disease. Achieving complete remission is critical to help maintain kidney function and delay or prevent the onset of serious and potentially fatal complications. Genentech is committed to harnessing pioneering science and innovation to address critical unmet needs for patients with immune-mediated inflammatory diseases. Our pipeline includes over a dozen clinical programs in immunology aiming to transform care for people living with lupus, MASH, ulcerative colitis, Crohn’s disease, immunoglobulin A nephropathy, idiopathic nephrotic syndrome, atopic dermatitis, and rheumatoid arthritis. We are investing end-to-end in immunology from discovery to R&D to commercialization across a variety of modalities including monoclonal antibodies, bispecifics, and CAR-T cell therapies to help solve some of the most difficult challenges in immunology today. Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. The content above comes from the network. if any infringement, please contact us to modify.