Novartis (NVS) said Thursday the US Food and Drug Administration has approved Fabhalta to treat adults with C3 glomerulopathy, the first therapy cleared for the condition.
The oral drug is designed to reduce protein in urine and targets a part of the immune system thought to drive the disease, the company said.
Data from a phase 3 trial showed a sustained drop in protein levels over one year, with no unexpected safety issues reported.
C3G is an uncommon kidney disorder usually diagnosed in young adults and often ends in kidney failure within a decade, according to Novartis.
The company said the treatment is also being reviewed in other regions, including Europe, China, and Japan.
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