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 therapeutic and dual antagonist of the BAFF and APRIL cytokines with potential in IgAN and other B cell-driven diseases. BTD is for a drug that treats a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over existing treatments.
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