Vertex unfazed by competitive IgAN space as FDA verdict looms

News Business Vertex unfazed by competitive IgAN space as FDA verdict looms August 4, 2026 | 2 min read | Tristan Manalac Twitter LinkedIn Facebook Email Print 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). 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 Twitter LinkedIn Facebook Email Print IgA nephropathy Regulatory Earnings Vertex Pharmaceuticals Tristan Manalac Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.