Release Date: 07-Sep-2021
US FDA has allowed orphan drug designation to apraglutide, a next-generation, long-acting GLP-2 analog being developed for rare gastrointestinal (GI) diseases, for the prevention of acute graft-versus-host disease (aGVHD). Gastrointestinal damage is a leading cause of death in patients with acute GVHD. GVHD is an extreme, 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. In the first quarter of 2022, VectivBio plans to initiate a Phase 2 trial evaluating apraglutide for the treatment of aGVHD.
The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S and it also gives several benefits, like tax credits for qualified clinical trials, potential seven years of market exclusivity after approval and exemption from user fees.