The atacicept FDA approval that the nephrology community had been anticipating since January arrived on schedule on 7 July 2026, when the US Food and Drug Administration granted accelerated approval to Vera Therapeutics’ atacicept-vymj, to be marketed as Trutakna, for reducing proteinuria in adults with primary IgA nephropathy who are at risk of disease progression. The decision makes Trutakna the first and only approved therapy that inhibits both B-cell activating factor and a proliferation-inducing ligand, the two cytokines thought to sit furthest upstream in the disease’s pathology.
The atacicept FDA approval is based on a prespecified interim analysis of the ongoing phase 3 ORIGIN 3 trial, in which patients treated with the drug achieved a 46 per cent reduction from baseline in urinary protein-to-creatinine ratio, a statistically significant and clinically meaningful 42 per cent reduction compared with placebo at week 36. As with other recent IgA nephropathy approvals, the decision rests on proteinuria as a surrogate endpoint. The FDA has stated that it has not been established whether Trutakna slows long-term kidney function decline, and continued approval for the indication may depend on verification of clinical benefit from the confirmatory portion of ORIGIN 3, which continues in a placebo-controlled, blinded manner and is due to report kidney function data in the third quarter of 2026.
What the Atacicept FDA Approval Covers
Trutakna is dosed at 150 milligrams, injected subcutaneously once a week and self-administered at home via an autoinjector. In the registrational safety population of 428 patients who received at least one dose of drug or placebo, the therapy was generally well tolerated. The most common adverse reactions occurring in at least 5 per cent of patients were infections, seen in 32 per cent of the atacicept group against 28 per cent on placebo, and local administration reactions, seen in 30 per cent against 5 per cent. Upper respiratory tract infection was the most frequent infection, and injection site reaction and erythema accounted for most local reactions. No serious, severe or opportunistic infections were observed in the atacicept group, nor was there any sign of hypogammaglobulinaemia, and antidrug antibodies had no clinically significant effect on the drug’s pharmacokinetics or effectiveness over the 36 week treatment period.
The label carries warnings around immunosuppression and infection risk consistent with its mechanism. Prescribers are advised to assess patients for active infection before starting treatment, to delay initiation until any infection resolves, and to avoid live vaccines in the 30 days before or during treatment. Safety and effectiveness in pregnant women and in paediatric patients have not been established.
Voices From the Approval
Marshall Fordyce, Founder and Chief Executive of Vera Therapeutics, said the approval marked an important milestone with the potential to meaningfully transform the treatment landscape for a disease with significant unmet need. In comments to Fierce Pharma, he said Vera’s approach had been to intervene as far upstream in IgA nephropathy’s pathogenesis as possible. Richard Lafayette, Professor of Medicine and Director of the Glomerular Disease Center at Stanford University Medical Center and a principal investigator in the ORIGIN programme, said the drug gave nephrologists a new option targeting both cytokines considered central to the condition’s underlying biology. Bonnie Schneider, Director and Co-Founder of the IgA Nephropathy Foundation, welcomed the approval as a source of hope for a patient community that has waited more than two decades for new mechanisms of action to reach the clinic. Not all observers are without reservation. Some nephrologists have noted that accelerated approvals based on proteinuria endpoints do not guarantee long-term preservation of kidney function, and that the field remains in an early phase of understanding which patients benefit most from which mechanism.
A Crowded but Differentiated Field
Trutakna enters a treatment landscape that has expanded rapidly since the FDA’s first IgA nephropathy approval, Calliditas Therapeutics’ corticosteroid budesonide, in 2021. Since then regulators have cleared Travere Therapeutics’ dual endothelin and angiotensin receptor antagonist sparsentan, Novartis’s selective endothelin A receptor antagonist atrasentan and its complement inhibitor iptacopan, and Otsuka’s APRIL-only antibody sibeprenlimab, which reached the US market toward the end of 2025. Vera’s own account of atacicept’s positioning is that the drug intervenes as far upstream in the disease process as currently possible, by removing both signals that drive B-cells to produce the harmful antibodies implicated in the condition, rather than acting further downstream on inflammation, fibrosis or blood pressure.
The company is not likely to hold that upstream position alone for long. Vertex Pharmaceuticals’ povetacicept, a related BAFF and APRIL fusion protein, was accepted for accelerated approval review in IgA nephropathy in June, with a PDUFA target action date of 30 November 2026 based on interim data from the phase 3 RAINIER trial. How the two dual inhibitors compare in practice, on efficacy, safety and convenience, is likely to shape prescribing patterns over the next several years.
What Comes Next, and What It Means for the UK
For patients and clinicians, the near-term question is how quickly Trutakna reaches pharmacies and how payers respond to a drug entering a market that, by Vera’s own estimate, includes around 160,000 people with IgA nephropathy in the United States. For Vera, the more consequential milestone is still ahead. The company has said it expects the accelerated eGFR analysis from ORIGIN 3 in the third quarter of 2026 and plans to file a supplemental Biologics License Application for full approval before the end of the year, with a decision potentially following in 2027.
The US approval also has implications beyond American borders. Atacicept already holds an orphan medicine designation from the European Medicines Agency, granted in November 2024, and UK clinicians will be watching for a Medicines and Healthcare products Regulatory Agency filing in the wake of the US decision. The precedent set by sparsentan, which received an initial UK marketing authorisation in November 2024 before converting to standard approval in April 2025 and subsequently gaining a NICE recommendation for use across the NHS in England, offers a plausible template for how quickly a US accelerated approval can translate into UK patient access once a company pursues authorisation through the MHRA’s International Recognition Procedure. Whether atacicept follows that path, and how it might be priced and reimbursed on the NHS given typical US six figure annual costs for comparable biologics, is likely to become a live question in UK nephrology circles over the coming months. For background on how the decision took shape, see our earlier preview of the atacicept FDA decision.
Vera has also launched a patient support programme, Trutakna Tru Support, which includes insurance navigation and financial assistance for eligible commercially insured patients in the US. Shares in Vera Therapeutics rose by roughly 8 per cent in the hours following the announcement, taking the stock to around 43 dollars and the company’s market capitalisation to around 3 billion dollars, as analysts framed the approval as the moment Vera completed its transition from a clinical-stage biotechnology company into a commercial one.
For now, the milestone belongs to the interim analysis and to a mechanism many in the field have anticipated since the phase 2b data first emerged. Whether Trutakna converts that early promise into confirmed, durable protection of kidney function will depend on the ORIGIN 3 results still to come.
