VECT - VectivBio gets FDA orphan drug status for apraglutide in acute graft-versus-host disease

VectivBio Holding (VECT) announces that the U.S. FDA has granted orphan drug designation to apraglutide for the prevention of acute graft-versus-host disease ((aGVHD)).The FDA’s Orphan Drug Designation program is designed to advance the development of drugs and biologics intended to treat, prevent or diagnose rare diseases affecting less than 200K people in the U.S.Orphan drug status incentives and benefits may include seven years of market exclusivity post-regulatory approval, among other things.GVHD is a severe, rare condition which can result from receiving an allogeneic hematopoietic stem cell transplant and the immune cells from the donor attack the patient’s healthy cells.VectivBio plans to initiate a Phase 2 trial evaluating apraglutide for the treatment of aGVHD in the first quarter of 2022.

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VectivBio gets FDA orphan drug status for apraglutide in acute graft-versus-host disease