Posted by Michael Wonder on 25 Sep 2020
Mereo BioPharma receives FDA rare paediatric disease designation for setrusumab for the treatment of osteogenesis imperfecta
24 September 2020 - Mereo BioPharma today announces that the U.S. FDA has granted rare paediatric disease designation to setrusumab for the treatment of osteogenesis imperfecta.
Setrusumab is a fully humanised monoclonal antibody that inhibits sclerostin, a protein which inhibits the activity of bone-forming cells.
In Mereo’s Phase 2b ASTEROID study, setrusumab demonstrated a dose-dependent bone building effect and a trend of reduction in fractures in addition to being safe and well tolerated in adults with osteogenesis impertecta.
