Vertex Pharmaceuticals (VRTX) announced several important updates across its development program for povetacicept, an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF and APRIL cytokines. Following the announcement that the Food and Drug Administration granted Breakthrough Therapy Designation to pove for the treatment of IgAN, FDA recently granted a rolling review of the Biologics License Application for pove for this indication. Vertex expects to submit the first module to FDA for potential accelerated approval before the end of 2025. Vertex announced it has initiated OLYMPUS, a Phase 2b/3 pivotal study of pove for the treatment of pMN, the second indication in which pove has best-in-class potential. There are no therapies specifically approved for the treatment of pMN.
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