Posted by Michael Wonder on 20 Apr 2022
FDA grants regenerative medicine advanced therapy designation to AlloVir’s posoleucel for prevention of multiple life-threatening infections from six viruses in allogeneic haematopoietic cell transplant patients
20 April 2022 - Posoleucel’s third regenerative medicine advanced therapy designation marks an unprecedented regulatory distinction among cell and gene therapies.
AlloVir today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation to its lead investigational multi-virus-specific T cell therapy, posoleucel, for the prevention of clinically significant infections and disease from six devastating viruses that commonly impact high-risk adult and paediatric patients following allogeneic haematopoietic cell transplant – adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, human herpes virus-6 and JC virus.
