Orphan Drug Designation for Inhaled Nitric Oxide for Persistent Pulmonary Hypertension Of The Newborn
GeNO LLC announced that the FDA has granted orphan drug designation for its inhaled nitric oxide (delivered via the GeNOsyl MVG-2000 delivery system) for the treatment of persistent pulmonary hypertension in newborns (PPHN).
The orphan drug designation was granted based on a plausible hypothesis for clinical superiority over the approved nitric oxide product.
Nitric oxide relaxes vascular smooth muscle and when inhaled produces pulmonary vasodilation. Infants with PPHN have a high pulmonary vascular resistance leading to hypoxemia. Nitric oxide improves oxygenation.
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