Mesoblast receives RPD designation for Revascor from FDA

Mesoblast announced that the FDA has granted its allogeneic cell therapy Revascor, or rexlemestrocel-L, a Rare Pediatric Disease, or RPD, Designation following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome, or HLHS, a potentially life threatening congenital heart condition. RPD Designation is granted by the FDA for certain serious or life-threatening diseases which primarily affect children. On FDA approval of a Biologics Licensing Application for REVASCOR for the treatment of HLHS, Mesoblast may be eligible to receive a Priority Review Voucher that can be redeemed for any subsequent marketing application or may be sold or transferred to a third party. Results from a blinded, randomized, placebo-controlled prospective trial of REVASCOR conducted in the U.S. in children with HLHS were published in the December 2023 issue of the peer reviewed The Journal of Thoracic and Cardiovascular Surgery Open.