Genentech, a unit of Roche Holding AG (RHHBY), announced Tuesday that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application for Gazyva for the treatment of systemic lupus erythematosus (SLE).
The filing is supported by positive results from the Phase III ALLEGORY study, which showed a statistically significant and clinically meaningful improvement in the primary endpoint of SLE Responder Index 4 at 52 weeks, a measure assessing disease severity, symptoms and physical condition.
A decision from the regulator is expected by December 2026.
Gazyva is already approved in the U.S. and EU for the treatment of adults with lupus nephritis.
For comments and feedback contact: editorial@rttnews.com
Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.