FDA Grants RMAT Designation To Mesoblast's Revascor For Pediatric Hypoplastic Left Heart Syndrome

(RTTNews) - Mesoblast Limited (MESO, MSB.AX) said that the U.S. Food and Drug Administration has granted its second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell therapy Revascor (rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) designation following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congenital heart condition.

Earlier this year, the FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for treatment of children with HLHS. RPDD demonstrates that the disease is serious or life-threatening and the manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents, and that the disease is a rare disease or condition.

On FDA approval of a BLA for REVASCOR for the treatment of HLHS, Mesoblast may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed for any subsequent marketing application or may be sold or transferred to a third party.

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