Iptacopan Hydrochloride

Otsuka Pharmaceuticals’ Voyxact is not the only IgA nephropathy drug that can slow the decline of kidney function. Vera Therapeutics’ Trutakna, which the FDA granted accelerated approval last month, showed “impressive” stabilization, analysts say. In June, Otsuka Pharmaceuticals touted data suggesting its IgA nephropathy drug Voyxact could slow the decline of kidney function in patients—a unique benefit, analysts said at the time. Now, Vera Therapeutics seems to have taken that distinguishing advantage away with the newly approved product Trutakna, which similarly elicited “promising” kidney function improvements, the FDA said. These findings come from the Summary Basis for Approval document for Trutakna, released by the agency last Thursday. In the pivotal Phase 3 ORIGIN 3 study, patients on Vera’s drug showed “impressive” stabilization in estimated glomerular filtration rate (eGFR), a key measure of kidney function, through 52 weeks, Guggenheim Securities told investors in an Aug. 14 note. The FDA called Trutakna’s eGFR improvements “promising,” but ultimately found them insufficient to draw definitive conclusions regarding the drug’s kidney benefits. Rather, Trutakna’s accelerated approval last month was based on proteinuria, a biomarker of IgAN. Indeed, Guggenheim cautioned that the kidney function data came from a “limited number of patients,” adding that the finalized analysis of ORIGIN 3 is up for presentation at a medical congress later this year. Digging deeper into the eGFR dynamics of patients on Trutakna, Jefferies analysts detected a “bump” in the measure at four weeks—similar to that observed with Voyxact. Thereafter, Trutakna’s eGFR trajectory “remains relatively flat and compares favorably” with that of Voyxact, the analysts wrote in an Aug. 14 note. Beyond 52 weeks, additional 60-week and 72-week data—though from fewer patients this time—continue to demonstrate further kidney function stabilization, again matching Voyxact, according to Jefferies. Otsuka energizes IgA neuropathy space with new Phase 3 Voyxact data By inhibiting the APRIL cascade, Otsuka Pharmaceuticals’ Voyxact slowed kidney function decline in patients with IgAN, opening up a potential path for full approval while also reading through to Vertex and others with similar assets. When Otsuka announced in June that Voyxact elicited eGFR improvements, analysts noted that the kidney benefits could set the drug apart from competing products. RBC Capital Markets at the time contended that the Voyxact readout represents “the first time we have seen this [eGFR stabilization] shown clearly in a placebo-controlled study.” Investors as a result increasingly took “a more cautious stance” toward Vera’s Trutakna, leery of the asset’s ability to compete with Voyxact, Guggenheim said. Vera could now have allayed some of those concerns, Jefferies contended. “We view this as reassuring and supportive of the view that [Trutakna’s] long-term eGFR pro ultimately track closely” to Voyxact. Aside from Voyxact, Trutakna is competing with Novartis’ Fabhalta in IgAN. Fabhalta was originally granted accelerated approval in August 2024 , which was converted to full approval last month. The content above comes from the network. if any infringement, please contact us to modify.

iStock, Yutthana Gaetgeaw Positive two-year follow-up data for Otsuka Pharmaceuticals’ IgA nephropathy drug Voyxact could support the FDA’s ongoing review of Vertex Pharmaceuticals’ povetacicept, CEO Reshma Kewalramani said on the company’s second quarter earnings call. Rather than feel pressured by how well rivals are doing, Vertex Pharmaceuticals’ CEO Reshma Kewalramani is encouraged by the competition in the IgA nephropathy space—and sees good opportunity for the big biotech’s upcoming drug povetacicept. The strong performance of other IgAN players “bodes very well” for povetacicept, Kewalramani said during Vertex’s second quarter earnings call Mondayafternoon. The FDA is currently reviewing the drug for accelerated approval, with a decision expected on or before Nov. 30 . While Kewalramani didn’t specifically name a competitor, she did refer to an asset for which findings were disclosed the day of the call. On Monday, Otsuka Pharmaceuticals released two-year findings from the Phase 3 VISIONARY trial of Voyxact, touting improvements in kidney function, as measured by estimated glomerular filtration rate (GFR). ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); Voyxact treatment resulted in a 0.3 mL/min/1.73 m² per year slope, whereas placebo controls showed a negative slope of 4.2 mL/min/1.73 m² annually, according to Otsuka’s release. These findings mark the first time an FDA-approved IgAN therapy demonstrated “stabilization of kidney function, with evidence of improvement,” the Japanese pharma said. Voyxact was granted accelerated approval in November 2025 based on a 51% placebo-adjusted reduction in urine protein concentrations (proteinuria), which at the time was considered a reasonable predictor of clinical benefit on kidney function. Otsuka in June initiated a rolling submission to seek full approval for Voyxact, with VISIONARY at the core of its package. IgA nephropathy Otsuka energizes IgA neuropathy space with new Phase 3 Voyxact data By inhibiting the APRIL cascade, Otsuka Pharmaceuticals’ Voyxact slowed kidney function decline in patients with IgAN, opening up a potential path for full approval while also reading through to Vertex and others with similar assets. June 5, 2026 · 2 min read · Tristan Manalac Read more “If anybody needed a little bit more conviction, you can certainly look at these data that were presented today,” Kewalramani said on the call. “Look at the proteinuria reduction, look at the GFR, and reconfirm for yourselves that significant reductions in proteinuria should and have resulted in GFR stabilization.” Following in the footsteps of Otsuka, Vertex is gunning for an accelerated approval for povetacicept with urinary protein data. Topline results from the Phase 3 RAINIER trial in March showed a 49.8% reduction in proteinuria at 36 weeks versus placebo—an outcome that Kewalramani on the call described as “very strong numbers.” She added that povetacicept has an edge because of the drug’s “patient-centric attributes of delivery.” Indeed, in contrast to Voyxact’s prefilled syringe , povetacicept would come as an autoinjector, making it easier to self-administer, Kewalramani said on the call. Stifel appeared to agree, with analysts in a Monday note saying that povetacicept’s “product profile”—including the monthly schedule—"does stand out.” While a monthly frequency doesn’t necessarily give povetacicept an edge over Voyxact, which is also meant to be given every four weeks, the schedule does provide a key advantage over Novartis’ Fabhalta , taken orally twice-daily, and Vera Therapeutics’ Trutakna , a weekly subcutaneous injection. IgA nephropathy Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for their recently approved IgAN therapies Fabhalta and Trutakna. July 20, 2026 · 2 min read · Tristan Manalac Read more