Posted by Michael Wonder on 29 Nov 2021
U.S. Food and Drug Administration approves Longeveron’s Lomecel-B for rare paediatric disease designation to treat life-threatening infant heart condition
18 November 2021 - Phase 2 clinical trial underway for hypoplastic left heart syndrome, which affects approximately 1,000 babies per year.
Longeveron announced today that the U.S. FDA has granted rare paediatric disease designation for Lomecel-B for the treatment of hypoplastic left heart syndrome, a rare and life-threatening congenital heart defect in infants.
Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signalling cell product, is currently being evaluated in a Phase 2 trial.
