FDA accepts supplemental Biologics License Application for Roche's Gazyva/Gazyvaro for the treatment of lupus nephritis
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The FDA has accepted Roche's supplemental Biologics License Application for Gazyva/Gazyvaro for treating lupus nephritis, based on positive phase III study results. A decision is expected by October 2025.
March 05, 2025 | 6:15 am
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Roche's sBLA for Gazyva/Gazyvaro in lupus nephritis has been accepted by the FDA, with a decision due by October 2025. This follows positive phase III results, potentially boosting Roche's market position.
The FDA's acceptance of the sBLA for Gazyva/Gazyvaro, based on positive phase III results, is a significant regulatory milestone for Roche. This could lead to an expanded market for the drug, positively impacting Roche's stock price in the short term.
CONFIDENCE 95
IMPORTANCE 80
RELEVANCE 90