Vera Therapeutics receives FDA accelerated approval for Trutakna, an IgA nephropathy drug showing promising kidney function stabilization

Vera Therapeutics announced that its IgA nephropathy therapy Trutakna has been granted accelerated approval by the U.S. Food and Drug Administration. The approval follows the agency's review of data submitted last month.

In the pivotal Phase 3 ORIGIN 3 trial, patients treated with Trutakna demonstrated impressive stabilization of estimated glomerular filtration rate (eGFR) over a 52‑week period, a key indicator of kidney health, according to analysts at Guggenheim Securities.

The FDA based the accelerated approval on reductions in proteinuria, a biomarker of IgA nephropathy, rather than definitive evidence of kidney function benefit. While the agency described the eGFR findings as promising, it noted that the data were insufficient to draw firm conclusions about long‑term renal outcomes.

The news positions Trutakna alongside Otsuka Pharmaceuticals’ Voyxact, another therapy that has shown the ability to slow kidney function decline in IgA nephropathy, potentially expanding treatment options for patients with the disease.