Vertex Pharmaceuticals’ CEO Reshma Kewalramani said on Aug. 4 that the company is encouraged by growing competition in the IgA nephropathy (IgAN) treatment space as it awaits a regulatory decision for its drug candidate povetacicept. The Food and Drug Administration is currently reviewing povetacicept for accelerated approval, with a decision expected on or before Nov. 30.
Kewalramani said during Vertex’s second quarter earnings call that the strong performance of other companies developing IgAN therapies “bodes very well” for povetacicept. While she did not mention specific competitors, she referred to data released earlier in the day by Otsuka Pharmaceuticals from its Phase 3 VISIONARY trial of Voyxact, which showed improvements in kidney function measured by estimated glomerular filtration rate (GFR). According to Otsuka, Voyxact treatment resulted in a 0.3 mL/min/1.73 m² per year slope, compared to a negative slope of 4.2 mL/min/1.73 m² annually among placebo controls.
Otsuka described these findings as the first demonstration by an FDA-approved IgAN therapy of “stabilization of kidney function, with evidence of improvement.” Voyxact received accelerated approval in November 2025 based on a reduction in urine protein concentrations (proteinuria), and Otsuka began seeking full approval for the drug in June with data from VISIONARY supporting its application.
“If anybody needed a little bit more conviction, you can certainly look at these data that were presented today,” Kewalramani said during 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.”
Vertex is also pursuing accelerated approval for povetacicept using urinary protein data from its own clinical trials. Results from Vertex’s Phase 3 RAINIER trial released earlier this year showed a 49.8% reduction in proteinuria at 36 weeks compared to placebo—an outcome Kewalramani called “very strong numbers.” She added that povetacicept may have an advantage due to patient-friendly delivery as an autoinjector versus Voyxact’s prefilled syringe.
Analysts at Stifel commented Monday that povetacicept’s product profile—including monthly dosing—"does stand out." While both povetacicept and Voyxact are administered every four weeks, this schedule differs from other recently approved therapies such as Novartis’ Fabhalta (taken orally twice daily) and Vera Therapeutics’ Trutakna (a weekly subcutaneous injection).
