Mesoblast Seeks ODD For Rexlemestrocel-L In Treating Severe Congenital Heart Disease

(RTTNews) - Mesoblast Limited (MESO,MSB.AX) said that it has filed for orphan drug designation or ODD and rare pediatric disease designation (RPDD) with the United States Food and Drug Administration or FDA for its allogeneic cell therapy Revascor (rexlemestrocel-L) in the treatment of the congenital heart disease hypoplastic left heart syndrome or HLHS.

HLHS is a severe congenital heart disease in which the left side of the heart does not fully develop and effective pumping of oxygenated blood by the left ventricle to the rest of the body is reduced. Without immediate surgery after birth, the prognosis is dismal with HLHS overall being responsible for 25% to 40% of all neonatal cardiac mortality.

The FDA has authority to grant orphan drug (OD) designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition, defined as any disease or condition that affects less than 200,000 persons in the United States.

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