U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Longeveron’s Lomecel-B™ Product for Treatment of Hypoplastic Left Heart Syndrome (HLHS) in Infants
Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently in a Phase 2a trial for HLHS.
- Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently in a Phase 2a trial for HLHS.
- The Fast Track Designation must continue to be met or FDA can withdraw the designation.
- The FDA previously granted Longeverons Lomecel-B Orphan Drug and Rare Pediatric Disease designations in November of 2021 for HLHS.
- Fast Track Designation represents a significant milestone in our efforts to develop Lomecel-B as a treatment for infants with HLHS, said Chris Min, M.D., Ph.D., Longeverons Interim Chief Executive Officer and Chief Medical Officer.