The trials -- ELOWEN-1 and ELOWEN-2 -- are designed to evaluate the drug in people living with lupus who experience active skin manifestations
The approval was driven by data from the Phase III TULIP-SC trial
Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage
CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions
The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation
Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion
The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
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