Vertex: FDA Grants Breakthrough Therapy Designation To Povetacicept

(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.

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