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Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. Saphnelo is also being evaluated for SLE in the European Union and Japan.
Fabhalta works by inhibiting factor B, a key enzyme in the alternative complement pathway, thus calming the damaging immuneresponse. The APPEAR-C3G Phase III study enrolled 74 adults with biopsy-confirmed C3G. In this study, Fabhalta produced a 35% reduction in proteinuria after six months compared to placebo.
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