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.
The odds are ever in favor of Vertex Pharmaceuticals’ povetacicept, under regulatory review for IgA nephropathy, after key FDA approvals in recent weeks.
Friday, the agency granted full approval to Novartis’ Fabhalta for IgAN, making it the only complement inhibitor indicated to slow the worsening of kidney function for the disease. Fabhalta was first granted accelerated approval in August 2024. Just days before the full approval, the FDA also cleared Vera Therapeutics’ atacicept—now branded as Trutakna—for IgAN.
These approvals, analysts at BMO Capital Markets said, are likely to provide a tailwind for Vertex’s povetacicept, an application for which is being reviewed by the FDA with a target action date of Nov. 30—and could help make up for the biotech’s late entry into the market.
“Vertex may not be first to the game,” the analysts said in a July 17 note, “but is likely to benefit from ongoing educational/awareness-enhancing efforts from competing manufacturers.” Also in Vertex’s favor is the biotech’s “international footprint” and “history of commercial execution,” BMO said.
Povetacicept is a fusion protein therapeutic that works by inhibiting both BAFF and APRIL cytokines, in turn suppressing the immune pathways that drive IgAN. In March, topline Phase 3 data showed a 49.8% decrease in urine protein creatinine ratio (UPCR), an indicator of kidney damage, at 36 weeks in patients on povetacicept versus placebo.
Analysts are keeping a close eye on how povetacicept’s review goes, with BMO in a May 5 note telling investors that an approval could trigger an evolution of Vertex’s business in a way “that may be nothing short of iconic.”
Fabhalta’s full approval now provides the benchmark for povetacicept moving forward, the group wrote on Friday. Data from Novartis’ Phase 3 APPLAUSE-IgAN study showed that over two years of follow-up, Fabhalta resulted in significant and clinically meaningful improvements in kidney function, as measured by the estimated glomerular filtration rate (eGFR).
This outcome “sets the efficacy bar Vertex will need to exceed for durable differentiation” when the company presents two-year data for povetacicept next year, BMO wrote. The firm is nevertheless confident in povetacicept, pointing to the drug’s “superior reductions in UPCR.” Although there have been no head-to-head studies comparing povetacicept and Fabhalta, Novartis’ drug elicited a 44% UPCR reduction in APPLAUSE-IgAN, leading to its accelerated approval.
“It is widely accepted that the extent of UPCR reduction generally increases the likelihood of more meaningful long-term eGFR outcomes,” BMO said. Given povetacicept’s superior UPCR benefits, “we could potentially see even greater slowing in eGFR decline from the asset.”
