Vera Therapeutics received priority review from the FDA for its biologics license application for atacicept to treat adults with immunoglobulin A nephropathy.
The application was submitted under the FDA’s accelerated approval program and assigned a Prescription Drug User Fee Act target action date of July 7, 2026. If approved, atacicept would become the first B-cell modulator targeting both B-cell activating factor and a proliferation-inducing ligand for IgAN, delivered as a once-weekly subcutaneous injection via autoinjector for at-home use, according to a Jan. 7 Vera Therapeutics news release.
The application is supported by data from a 431-patient, phase 3 trial, Origin 3, in which atacicept achieved a 46% reduction in proteinuria from baseline and a 42% reduction compared to placebo at week 36. The safety profile appeared favorable and comparable to placebo.
Vera has administered atacicept to more than 1,500 patients across various disease areas. The therapy is also being evaluated in other autoimmune kidney diseases, including primary membranous nephropathy and focal segmental glomerulosclerosis.
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