Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
Vera Therapeutics has received accelerated FDA approval for atacicept to treat adults with the autoimmune kidney disease primary IgA nephropathy. The recombinant fusion protein therapy will now be marketed as Trutakna—with a clean label, analysts noted—and compete with Otsuka’s Voyxact and Novartis’ Fabhalta.
The therapy was specifically approved to lower proteinuria in patients who have primary IgAN and are at risk of further disease progression. In an interim analysis from the ongoing Phase 3 trial ORIGIN 3, patients who received Trutakna achieved a 46% reduction from baseline in proteinuria, a key biomarker of the disease when protein builds up in the urine. As compared to placebo, the reduction was 42% at 36 weeks.
Vera’s shares rose more than 8% on Tuesday afternoon to $43.47. The company will hold a conference call at 4:30 p.m. ET.
Vera has not yet shown that the therapy slows kidney function decline over the long term, the FDA noted in the approval announcement. Therefore, the biotech will have to confirm that clinical benefit to achieve a full approval. Vera plans to do so with data from the ongoing ORIGIN 3 trial, with results expected in the third quarter.
IgAN is the leading cause of chronic kidney disease or failure worldwide, Vera noted in its own release. Trutakna will be the first available medicine for the condition that targets both B cell activating factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which are involved in survival and maturation of certain immune cells, the FDA noted. Targeting both allows for a decrease in abnormal IgA antibody production.
The label granted by the FDA, analysts from Guggenheim wrote on Tuesday afternoon, provides a bit of a leg up for Vera over existing rivals such as Otsuka’s APRIL inhibitor Voyxact, which was approved by the FDA late last year.
“The product label is inline with our bullish expectations,” Guggenheim said. “We are encouraged that the product received a broad approval with no limitations on use based on proteinuria levels and that there is no mention of neutralizing antibodies in the label, unlike what we have seen with Otsuka’s (4578-JP) Voyxact.”
Vera will now battle it out in a crowded market. Beyond Otsuka, Novartis’ complement inhibitor Fabhalta is approved in the indication, while Vertex Pharmaceuticals submitted an accelerated application for povetacicept in June. The FDA has set a Nov. 30 decision date for Vertex’s candidate.
Correction (July 10): This story has been updated to reflect that Otsuka’s APRIL inhibitor Voyxact was approved for patients at risk of disease progression, not those at high risk. BioSpace regrets the error.
