The FDA approved a New Drug Application (NDA) from GeNO LLC for review of the company’s GeNOsyl™ MVG-2000 Nitric Oxide Delivery System for neonates with hypoxic respiratory failure.
GeNOsyl nitric oxide for inhalation is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension; it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.
“We are pleased with the FDA’s acceptance of our NDA submission for review as it is a significant achievement in the regulatory approval process,” said David Fine, GeNO president and founder. “The FDA’s acceptance for filing of this NDA follows 510(k) clearance earlier this year of GeNO’s MV-1000 inhaled nitric oxide delivery system, and orphan drug designation of GeNOsyl™ (nitric oxide delivered via the MVG-2000 delivery system). We believe that GeNO’s novel nitric oxide delivery systems have the potential to transform the treatment of pulmonary hypertension, and other conditions, by delivering a more pure form of nitric oxide for inhalation that contains lower levels of nitrogen dioxide and is less costly.”
GeNO has completed a Phase 2 pilot study of its nitric oxide for use as a diagnostic in pulmonary arterial hypertension (PAH) and is currently performing a dose-escalation trial for the treatment of pulmonary hypertension in patients with PAH and pulmonary hypertension secondary to idiopathic pulmonary fibrosis (PH-IPF).