The FDA has accepted Roche's (RHHBY) supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro as a potential new treatment for systemic lupus erythematosus (SLE), the most common and often life-threatening form of lupus.
A Step Toward a New Treatment Option
The filing is supported by results from the Phase III ALLEGORY study, which showed that Gazyva/Gazyvaro (obinutuzumab) significantly reduced disease activity compared with placebo in adults with SLE. The trial measured improvement using the SLE Responder Index 4 (SRI-4), a standard tool that tracks changes in symptoms, physical condition, and overall disease severity.
If approved, Gazyva/Gazyvaro would become the first anti-CD20 therapy specifically targeting B cells for SLE- a major milestone for a condition affecting more than three million people worldwide. Better disease control can help reduce painful flares and may prevent long-term organ damage.
Key Findings From the ALLEGORY Study
More than three-quarters of patients (76.7%) receiving Gazyva/Gazyvaro plus standard therapy achieved a least a four-point improvement in SRI-4 at 52 weeks, compared with just over half of those on placebo. Safety results were consistent with the medicine's known profile, with no new concerns identified.
The therapy also outperformed placebo across multiple secondary measures, including flare reduction, remission rates, and sustained lowering of steroid use- an important goal for patients who often rely on long-term corticosteroids.
Broader Clinical Program
The ALLEGORY study is one of four positive Phase III trials evaluating Gazyva/Gazyvaro in immune-mediated diseases, adding to evidence from REGENCY study in lupus nephritis, INShore in idiopathic nephrotic syndrome and MAJESTY in primary membranous nephropathy. Roche has also submitted the data package to the European Medicines Agency.About Gazyva/GazyvaroGazyva/Gazyvaro is a humanised monoclonal antibody designed to target CD20-positive B cells, which play a central role in lupus. It is already approved in more than 100 countries for several blood cancers and for lupus nephritis in the U.S. and EU.
Roche stated that the FDA's acceptance brings the company closer to offering a new treatment option for people living with SLE, a disease that can take years to diagnose and often leads to irreversible organ damage if not adequately controlled. A final FDA decision is expected by December 2026.
"For people living with SLE, the daily challenges of the disease can be both physically and emotionally overwhelming," said Albert T. Roy, President and CEO, Lupus Research Alliance. "We are hopeful for the approval of Gazyva as a new treatment for SLE — given its potential to manage symptoms as well as drive higher rates of clinical remission and reduce the frequency of debilitating flares.''
The company is scheduled to report its Q1 2026 financial results on April 23, 2026.
RHHBY has traded between $35.07 and $60.85 over the past year. The stock closed Monday's trading at $51.33, up 0.27%.
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