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.
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 profile could 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.
