FDA approves Trutakna for IgA nephropathy
The US FDA granted accelerated approval to Trutakna (atacicept-vymj) on 7 July 2026 to reduce protein in the urine in adults with primary IgA nephropathy.
Key points
- The US FDA granted accelerated approval to Trutakna (atacicept-vymj) on 7 July 2026.
- It is an injection for adults with primary IgA nephropathy at risk of disease progression.
- The approval rests on a reduction in proteinuria; the FDA says it is not established whether the medicine slows kidney function decline.
- This is a US decision; UK availability is decided separately.
What was announced
On 7 July 2026 the US Food and Drug Administration (FDA) granted accelerated approval to Trutakna (atacicept-vymj), an injection given under the skin.
It is approved for adults with primary IgA nephropathy, a kidney disease, who are at risk of the disease getting worse.
The FDA describes it as the first approved medicine that targets both BAFF and APRIL, two signalling proteins involved in the survival and maturation of certain immune cells.
What it means
Accelerated approval here rests on a reduction in proteinuria, which means protein in the urine.
The FDA states that it has not been established whether Trutakna slows the decline in kidney function over the long term, and that an ongoing trial must be completed to confirm this.
The efficacy and safety data come from a randomised, double-blind, placebo-controlled trial in adults with biopsy-confirmed IgA nephropathy.
This is a US decision; availability in the UK is decided separately by the MHRA and NICE.
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