What's Happening?
Vera Therapeutics is preparing to submit a biologics license application (BLA) to the FDA for its drug atacicept by the end of the year. This decision follows promising results from a Phase III study,
known as the ORIGIN study, which demonstrated that atacicept significantly reduced urinary protein levels in patients with IgA nephropathy (IgAN). The study reported a 46% reduction in proteinuria at 36 weeks compared to baseline, and a 42% reduction when compared to placebo. Additionally, the trial met its secondary endpoints, including a 68% reduction in a disease biomarker and cessation of blood in urine in 81% of patients. Analysts from Guggenheim Partners have praised the drug's efficacy and safety profile, noting fewer serious adverse events compared to placebo. The ORIGIN study is ongoing and is expected to complete in 2028.
Why It's Important?
The potential approval of atacicept could mark a significant advancement in the treatment of IgA nephropathy, a chronic kidney disease with limited treatment options. If approved, atacicept would be the first APRIL/BAFF inhibitor available for IgAN, offering a new mechanism of action for managing the disease. This development is crucial as it could provide a new first-line disease-modifying therapy, potentially improving long-term outcomes for patients. The drug's approval could also position Vera Therapeutics as a leader in the competitive IgAN treatment landscape, ahead of other companies like Vertex Pharmaceuticals, which is also developing similar therapies. The introduction of atacicept could influence treatment protocols and offer a new standard of care for IgAN patients.
What's Next?
Vera Therapeutics plans to file the BLA for atacicept in the fourth quarter, with a potential product launch anticipated by mid-2026. This timeline would place Vera slightly behind Otsuka's sibeprenlimab, which has an FDA decision date set for November 28. However, an approval by mid-2026 would still allow Vera to be ahead of other competitors in the market. The ongoing ORIGIN study will continue to provide data that could further support atacicept's efficacy and safety profile. As the competitive landscape for IgAN treatments evolves, stakeholders will be closely monitoring the FDA's decision and the subsequent market dynamics.
