The Food and Drug Administration has cleared a new treatment from Vera Therapeutics in the latest step forward for an emerging class of medications that have shown the ability to combat a rare and potentially life-threatening kidney disease.
Previously known as atacicept and to be sold as Trutakna, the drug on Tuesday was approved to treat adults with IgA nephropathy or “IgAN,” a chronic condition that can lead to kidney failure. The FDA granted its developer, Vera, an accelerated approval based on testing showing Trutakna’s ability to lower levels of protein in the urine, a key marker of disease progression. Vera must confirm Trutakna’s benefits through additional testing for the clearance to be converted to a standard approval. Data are expected in the third quarter.
The drug will have an annual list price of $425,000 per year, executives announced on a conference call Tuesday. That price tag comes in notably higher than the $390,000 wholesale acquisition cost of Voyxact, a similar kind of drug that Otsuka Pharmaceutical brought to market last year. But unlike Voyxact, Trutakna targets two cytokines implicated in IgAN instead of one, a mechanism Vera believes to yield a superior impact. It’s also self-administered weekly via a pre-filled autoinjector, rather than once-monthly through a syringe.
“Until now, we have lacked a therapy that can comprehensively address the key upstream drivers of IgAN pathophysiology. Trutakna does exactly that,” said CEO Marshall Fordyce, on the conference call.
Vera estimates that about 160,000 people in the U.S. are affected by IgAN, a progressive disease that damages the kidneys. While several therapies are available, they don’t halt patients’ persistent decline in kidney function. The need for better options has spurred multiple drug developers to seek better options, often through dealmaking.
Several of these newer medications target specific immunological drivers of IgAN. Otsuka’s Voyxact last year became the first approved treatment designed to block the inflammatory cytokine “APRIL.” Trutakna, and some others behind it, homes in on APRIL as well as a second cytokine “BAFF” also involved in the errant immune response in IgAN.
Clinical testing showed that Trutakna was able to reduce protein levels in the urine by 46% after 36 weeks of treatment. The most common side effects associated with treatment were upper respiratory tract infections, injection site reactions and a kind of skin redness.
The drug’s prescribing information was “generally competitive” with Voyxact, but Otsuka still has “distinct first-to-market advantages,” wrote William Blair analyst Myles Minter.
In a separate note, Jefferies analyst Farzin Haque wrote that Vera has the “most robust dataset” so far, which likely supports its decision to price its drug at a premium to Voyxact.
"Ultimately, it will come down to commercial execution between the sponsors," Haque added.
