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Investing.com -- The U.S. Food and Drug Administration (FDA) has approved Roche Holding AG’s (SIX:RO) Gazyva/Gazyvaro (obinutuzumab) for treating adult patients with active lupus nephritis who are receiving standard therapy.
The approval, announced Monday, is based on positive results from phase II NOBILITY and phase III REGENCY studies. In the REGENCY trial, 46.4% of participants receiving Gazyva in combination with standard therapy achieved complete renal response compared to 33.1% on standard therapy alone.
Gazyva is the only anti-CD20 monoclonal antibody to demonstrate complete renal response benefit in lupus nephritis in a randomized phase III study. The FDA also approved a shorter 90-minute infusion time after the first infusion for eligible patients.
"The approval of Gazyva/Gazyvaro by the FDA marks an important step towards a potential new standard of care for lupus nephritis," said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.
Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of color and childbearing age. If left untreated, up to one-third of patients can progress to end-stage kidney disease, requiring dialysis or transplantation.
The FDA granted Gazyva Breakthrough Therapy Designation in 2019 based on data from the phase II NOBILITY study. The European Medicines Agency’s Committee for Medicinal Products for Human Use recently issued a positive opinion recommending approval, with a final decision expected soon.
Gazyva is a Type II engineered humanized monoclonal antibody that attaches to CD20, a protein found on certain B cells. In lupus nephritis, disease-causing B cells drive inflammation that damages kidneys. The drug is already approved in 100 countries for various types of hematological cancers.
Roche (SIX:ROG) is also investigating Gazyva for systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and in children and adolescents with lupus nephritis.