Neonatal Herpes Simplex Drug Designated Orphan Drug
N&N Pharmaceuticals Inc. announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for N-Methanocarbathymidine (N-MCT) for the treatment of neonatal herpes complex.
Neonatal herpes simplex, a life-threatening infection, often produces severe long-term sequelae in the newborn. The majority of neonates born with HSV-2 infection have a 1-year mortality even with aggressive treatment. More than half of surviving neonates experience long-term neurodevelopmental problems.
Preclinical studies have shown that N-MCT has shown significant protection of HSV-2 infection in newborn neonates. Also, N-MCT demonstrated superior activity towards shingles and genital herpes infection.
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