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.
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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.