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—for patients with IgA nephropathy at risk of disease progression—provided a bit of a leg up for Vera over existing rivals, analysts from Guggenheim wrote on Tuesday afternoon. Otsuka’s APRIL inhibitor Voyxact was approved by the FDA late last year for patients at high risk of disease progression, meaning Vera has been granted access to a broader patient population.
“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.”
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.
