Vertex Pharmaceuticals’ povetacicept, currently under regulatory review for IgA nephropathy, is viewed as having improved prospects following recent full approvals by the Food and Drug Administration of competing therapies. The agency granted full approval to Novartis’ Fabhalta for IgA nephropathy on Friday, making it the only complement inhibitor indicated to slow worsening kidney function in patients with the disease. Fabhalta had previously received accelerated approval in August 2024. Earlier in the same week, Vera Therapeutics’ atacicept—now branded as Trutakna—was also cleared by the FDA for IgA nephropathy.
Analysts at BMO Capital Markets said these developments are likely to provide a tailwind for Vertex’s povetacicept, which is being reviewed by the FDA with a target action date of Nov. 30. They said this could help offset Vertex’s later entry into the market compared to its competitors. “Vertex may not be first to the game,” analysts said in a July 17 note, “but is likely to benefit from ongoing educational/awareness-enhancing efforts from competing manufacturers.” BMO also cited Vertex’s “international footprint” and “history of commercial execution” as factors working in its favor.
Povetacicept is described as a fusion protein therapeutic that inhibits both BAFF and APRIL cytokines, suppressing immune pathways associated with IgA nephropathy. In March, topline Phase 3 data showed that patients receiving povetacicept experienced a 49.8% decrease in urine protein creatinine ratio at 36 weeks compared to placebo.
BMO Capital Markets told investors in a May 5 note that an approval could significantly change Vertex’s business trajectory: an evolution they described as potentially “nothing short of iconic.”
The full approval of Fabhalta now serves as a benchmark for povetacicept moving forward, according to BMO Capital Markets. Data from Novartis’ Phase 3 APPLAUSE-IgAN study showed significant improvements over two years in kidney function measured by estimated glomerular filtration rate (eGFR). While there have been no head-to-head studies between povetacicept and Fabhalta so far, analysts pointed out that Novartis’ drug achieved a 44% reduction in urine protein creatinine ratio during its trial.
“It is widely accepted that the extent of UPCR reduction generally increases the likelihood of more meaningful long-term eGFR outcomes,” BMO said. Given what they called superior UPCR benefits seen with povetacicept so far, analysts suggested there could be even greater slowing of eGFR decline if approved.
