Vera’s Trutakna Wins FDA Approval as First Dual IgAN Drug

The FDA on July 7, 2026 cleared Vera Therapeutics’ Trutakna as the first dual BAFF/APRIL inhibitor for adults with primary IgA nephropathy, an autoimmune kidney disease. Trutakna is the sixth drug to win a U.S. approval for IgAN, and the first in a new class that interferes with the two cytokines driving the abnormal antibody buildup in the kidneys. Vera Therapeutics, based in Brisbane, California, has been readying its commercial team for the launch since earlier this year.

The accelerated approval rests on a 42% reduction in urine protein at 36 weeks in the phase 3 ORIGIN 3 trial, not on the harder measure of whether the drug actually slows kidney decline. That second test arrives in the third quarter of 2026, and payers are expected to wait for it before opening broad coverage. Trutakna enters a market Otsuka stepped into late last year with Voyxact, and a third B-cell pathway competitor from Vertex is due to be reviewed by the FDA on November 30. Vera estimates the U.S. opportunity at about $20 billion, anchored to Otsuka’s pricing for the only other B-cell modulator on the market.

A Six-Year Path to the First Dual IgAN Therapy

Six years ago, when Vera Therapeutics in-licensed atacicept from Merck KGaA, no FDA-approved treatment existed for IgA nephropathy. The list has since grown to five drugs before Trutakna’s arrival, and the launch lands on a U.S. patient population estimated at 160,000.

The FDA cleared Trutakna to reduce proteinuria in adults with primary IgAN at risk for disease progression, per its July 7 approval release on the IgAN drug. The dose is 150 mg injected under the skin once weekly, self-administered at home through an autoinjector. The drug binds both B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL), the survival cytokines for the B cells that produce the abnormal IgA1 antibody that deposits in the kidneys. Trutakna had already won breakthrough therapy designation and a priority review before the decision.

Mechanistically, there are multiple places in IgAN pathogenesis to intervene, and Vera’s approach has been to intervene as far upstream as possible.

Marshall Fordyce, founder and CEO of Vera Therapeutics, made the comment in an interview with Fierce Pharma. The decision marks the first U.S. approval of a dual BAFF/APRIL inhibitor for IgAN and the sixth FDA-approved drug in the disease class.

The ORIGIN 3 Trial and the 42% Proteinuria Drop

ORIGIN 3 (NCT04716231) is a global, multicenter, randomized, double-blind, placebo-controlled phase 3 trial in adults with biopsy-confirmed IgA nephropathy. The FDA’s July 7 release described it as enrolling 431 patients, randomized one-to-one to Trutakna 150 mg weekly or placebo. The primary efficacy endpoint was the change in 24-hour urine protein-to-creatinine ratio (UPCR) at 36 weeks.

In a prespecified interim analysis, patients on Trutakna cut UPCR 46% from baseline and 42% compared to placebo (p<0.0001). The results were published in The New England Journal of Medicine and presented at the American Society of Nephrology Kidney Week, per the AJMC.

TRUTAKNA offers patients and their nephrologists an exciting new treatment advancement that inhibits both BAFF and APRIL, the two key cytokines that act on B cells, which are at the source of IgAN pathophysiology.

Richard Lafayette, MD, a Stanford University nephrologist and ORIGIN 3 principal investigator, made the comment in the Vera Therapeutics release.

• Trial: ORIGIN 3, randomized 1:1, double-blind, placebo-controlled, 431 adults with biopsy-confirmed IgAN
• Primary endpoint: 24-hour UPCR at 36 weeks in the first 203 patients dosed
• Result: 46% reduction from baseline, 42% vs placebo (p<0.0001)
• Secondary: 68% drop in galactose-deficient IgA1 (Gd-IgA1)
• Confirmatory eGFR readout: anticipated Q3 2026

Safety was the other half of the package. Infections hit 32% of Trutakna patients versus 28% on placebo, and local injection-site reactions hit 30% versus 5%. The FDA warns that Trutakna suppresses the immune system and may raise infection risk, so prescribers should screen for active infections before starting treatment and monitor for them during therapy. Live vaccines are off the table within 30 days of a dose.

On a secondary endpoint, Trutakna cut the autoantigen Gd-IgA1 by 68%, though that result carried no multiplicity adjustment. The harder confirmatory data, change in estimated glomerular filtration rate (eGFR), is still being collected under blinded, placebo-controlled conditions.

Why Hitting Both BAFF and APRIL Matters

IgAN begins when an abnormal form of immunoglobulin A builds up in the kidney, triggering inflammation that leaks protein into the urine and slowly scars the organ. At least half of patients progress to kidney failure or death within 10 to 20 years of diagnosis, and the disease is one of the leading drivers of a much larger wave in which chronic kidney disease has more than doubled in a generation. Vera’s release pegs U.S. prevalence at about 160,000 patients and global incidence at roughly 2.5 new cases per 100,000 adults each year, most often diagnosed between ages 30 and 40.

Trutakna is the first drug in the U.S. that inhibits both BAFF and APRIL at once, two cytokines that act on B cells to drive production of the galactose-deficient IgA1 that forms the immune complexes. By hitting both, Vera’s drug goes after the disease further upstream than Otsuka’s Voyxact, which targets APRIL alone and reached the U.S. market in November 2025. Voyxact posted a 51% placebo-adjusted UPCR reduction at 9 months in the VISIONARY trial, per the AJMC. Fordyce told Fierce Pharma that the goal is to ‘intervene as far upstream as possible’ in IgAN pathogenesis.

The early signal that Trutakna could deliver more than a proteinuria cut came in a phase 2b Origin trial, where patients on atacicept saw an average annualized eGFR decline of 0.6 mL/min/1.73 m² over 96 weeks. That rate matches the natural kidney aging seen in healthy adults, a far slower slope than typical IgAN patients experience. The figure sets up the case for full approval, but the agency still wants to see it confirmed in the larger, ongoing ORIGIN 3 dataset.

How Trutakna Stacks Up Against Five Other IgAN Drugs

The FDA’s first IgAN approval went to Calliditas Therapeutics’ corticosteroid Tarpeyo in 2021, Fierce Pharma recounted. The agency has since cleared Travere Therapeutics’ Filspari, a dual endothelin and angiotensin receptor antagonist, plus Novartis’ endothelin A receptor blocker Vanrafia and complement inhibitor Fabhalta. Otsuka’s Voyxact, an APRIL-only inhibitor, reached the U.S. market in late 2025.

Trutakna, Voyxact, and Vertex’s pending povetacicept are the three B-cell-pathway agents now in or near the U.S. market, each with different proteinuria numbers and dosing. Trutakna’s 42% placebo-adjusted UPCR cut at 36 weeks came in the 431-patient ORIGIN 3 trial. Voyxact posted a 51% placebo-adjusted UPCR reduction at 9 months in the VISIONARY trial. Povetacicept, a dual BAFF/APRIL inhibitor like Trutakna, posted a 49.8% placebo-adjusted UPCR reduction at 36 weeks in a phase 3 trial under FDA review with a November 30 target date.

The same B-cell class will produce three branded options within a year if Vertex lands its November decision. Krzysztof Kiryluk, chief of nephrology at Columbia University, told Jefferies that differentiation among BAFF/APRIL drugs will turn on two-year eGFR data, not on proteinuria. A June 21 Jefferies note summarized the conversation by saying that, if efficacy and eGFR outcomes are equivalent, ‘differentiation will hinge on safety, dosing convenience, monitoring requirements and insurance coverage/pricing.’

Povetacicept is dosed once every four weeks, the same as Voyxact, while Trutakna is a once-weekly autoinjector. The dosing difference could matter to adherence, but only real-world claims data will tell.

The eGFR Gate That Will Open Real Coverage

The FDA made clear in its approval letter that Trutakna has not been shown to slow kidney function decline over the long term. Continued approval is contingent on the confirmatory eGFR readout from ORIGIN 3, which is now anticipated in the third quarter of 2026. Vera plans to file a supplemental BLA for full approval in the fourth quarter of 2026.

Payers are expected to treat the proteinuria data as a launch pad, with broad coverage contingent on the Q3 2026 eGFR readout. Vera estimates the U.S. opportunity at about $20 billion, anchored to Otsuka’s pricing for Voyxact, and is initially targeting about 9,000 fast progressors in the United States. ‘The most important thing, I think, is safety, and having placebo-like safety is important,’ Fordyce told Fierce Pharma. Safety will also shape formulary design, because infections hit 32% of Trutakna patients versus 28% on placebo.

The competitive dynamic is reshaping in real time. Otsuka reported in early July that Voyxact stabilized kidney function in its VISIONARY long-term follow-up, a datapoint that narrows one of the clearest pre-launch gaps. Vera’s case for differentiation now rests on durability of eGFR benefit and on the head-to-head numbers from that Q3 2026 ORIGIN 3 readout.

Vera’s Next Three Moves After Approval

Vera has built a patient support program, TRUTAKNA TRU SUPPORT, that offers insurance coverage help and a $0 copay for eligible commercially insured patients, per Vera’s release on the Trutakna approval. The company hired its full sales force about three months ago, Fordyce said, drawing on people with prior blockbuster launches. Bonnie Schneider, co-founder of the IgAN Foundation, said the group has been a longstanding Vera partner focused on making the patient experience central to clinical research. The 22-year-old foundation’s mission, Schneider said, has been to encourage the development of innovative therapies.

Vera also plans to test Trutakna’s mechanism in other autoantibody-driven kidney diseases, including membranous nephropathy and focal segmental glomerulosclerosis. The company last year licensed a next-generation BAFF/APRIL fusion protein, coded VT-109, from Stanford University; Fordyce said the asset is preclinical and could move toward quarterly or less frequent dosing. The next milestones are the Q3 2026 eGFR readout, the Q4 2026 sBLA filing for full approval, and Vertex’s November 30 PDUFA date for povetacicept.

Frequently Asked Questions

What is Trutakna approved to treat?

The FDA cleared Trutakna on July 7, 2026 to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. The approval is accelerated, meaning continued marketing depends on a confirmatory trial showing the drug slows kidney function decline.

How does Trutakna work?

Trutakna is a recombinant fusion protein that binds both B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL), two cytokines that act on B cells to produce the abnormal IgA1 antibody that drives IgA nephropathy. It is the first U.S.-approved drug to inhibit both cytokines at once.

How is Trutakna taken?

Trutakna is a 150 mg subcutaneous injection given once a week, self-administered at home through an autoinjector. The dose and administration are set out in the FDA’s July 7 release and Vera’s prescribing information.

What are Trutakna’s main side effects?

In ORIGIN 3, infections hit 32% of Trutakna patients versus 28% on placebo, and local injection-site reactions hit 30% versus 5%. The FDA warns prescribers to screen for active infections before treatment, monitor during therapy, and avoid live vaccines within 30 days of a dose.

How does Trutakna compare to Otsuka’s Voyxact?

Voyxact targets APRIL alone and was approved November 25, 2025; Trutakna targets both BAFF and APRIL. Voyxact posted a 51% placebo-adjusted UPCR reduction at 9 months in VISIONARY; Trutakna posted a 42% placebo-adjusted UPCR reduction at 36 weeks in ORIGIN 3. Trutakna is dosed weekly and Voyxact every four weeks.

When will Trutakna be available?

Vera Therapeutics has been readying its commercial team since earlier this year, with a patient support program (TRUTAKNA TRU SUPPORT) and copay assistance already in place. The company has not announced a specific list price or launch date in its July 7 release.

Why is this an accelerated approval and what does that mean?

Accelerated approval lets the FDA clear a drug based on a surrogate endpoint, here the 42% reduction in urine protein, that is reasonably likely to predict clinical benefit. Trutakna must still show it slows kidney function decline in the ongoing ORIGIN 3 eGFR analysis, due in Q3 2026, or face potential withdrawal of the approval.

Disclaimer: This article is for informational purposes only and is not medical advice. Trutakna is a prescription drug; talk to a qualified healthcare professional about whether it is appropriate for you. Drug pricing, approval status, and clinical trial data cited here are accurate as of July 7, 2026, and may change.