Breakthrough Therapy Designation To Povetacicept
Vertex: FDA Grants Breakthrough Therapy Designation To Povetacicept
September 25, 2025. (RTTNews) - Vertex Pharmaceuticals (VRTX) announced that the FDA has granted Breakthrough Therapy Designation to povetacicept for the treatment of IgAN. Pove is an investigational recombinant fusion protein, and is currently being studied in RAINIER, a global Phase 3 clinical trial in patients with IgAN.
Vertex also announced enrollment completion of the IA cohort of AMPLITUDE, a global Phase 2/3 clinical trial designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with AMKD. If positive, the IA will serve as the basis for Vertex to seek accelerated approval of inaxaplin in the U.S.
The company also announced it has initiated AGLOW, a Phase 2 proof-of-concept study of VX-407 for the treatment of ADPKD.
Povetacicept is a potential new drug designed to treat B-cell-mediated autoimmune diseases by blocking the BAFF and APRIL cytokines, which are overactive in these conditions, leading to excessive B-cell survival and antibody production. It is an engineered TACI-Fc protein with high affinity and potency, showing promise in early clinical trials for reducing pathogenic autoantibodies and slowing disease progression in conditions like IgA nephropathy (IgAN) and primary membranous nephropathy (pMN).
Vertex Pharmaceuticals is developing povetacicept for various autoimmune diseases, including autoimmune kidney diseases and autoimmune cytopenias, and recently formed a partnership with Ono Pharmaceutical for its development in Japan and South Korea.
