福泰製藥：FDA 授予 Povetacicept 突破性療法資格
Vertex Pharmaceuticals (VRTX) has received Breakthrough Therapy Designation from the FDA for povetacicept, aimed at treating IgAN. This investigational recombinant fusion protein is currently in a global Phase 3 trial named RAINIER. Additionally, Vertex completed enrollment for the IA cohort of the AMPLITUDE trial, which evaluates inaxaplin's effects on kidney function, potentially leading to accelerated approval in the U.S. The company also launched AGLOW, a Phase 2 study for VX-407 targeting ADPKD.
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.
For More Such Health News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Business News
