Mallinckrodt’s INOmax Granted Approved In Japan and Australia For Pulmonary Hypertension In Conjunction With Heart Surgery

Mallinckrodt’s INOmax Granted Approved In Japan and Australia For Pulmonary Hypertension In Conjunction With Heart Surgery

Biopharmaceutical company Mallinckrodt plc., recently announced that INOmax® (nitric oxide) for inhalation has been approved in Japan for pulmonary hypertension associated with heart surgery.

INOmax is a vasodilator that improves ventilation/perfusion (V/Q) matching by reducing pulmonary vascular resistance (PVR). Inhaled NO improves V/Q matching by reducing PVR in term and near-term neonates with hypoxic respiratory failure (HRF) associated with pulmonary hypertension. Respiratory failure is a syndrome in which the respiratory system fails in one or both of its gas exchange functions: oxygenation and carbon dioxide elimination. In practice, it may be classified as either hypoxemic or hypercapnic.

The inhalation gas was the first treatment option for HRF to be approved in Australia in 2007 and in Japan in 2008, and it is approved in the US to increase oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) newborns with HRF related with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory maintenance and other suitable substances.

In the US, INOmax cannot be for use in patients older than newborns, and the FDA has not approved its use in surgical settings.

The new approvals involve:

  • INOmax® has been approved by The Australian Therapeutic Goods Administration (TGA) to be used in peri- and post-operative pulmonary hypertension in conjunction with heart surgery in new-borns throughout adolescence (patients aged up to 17 years). In 2007 it has been approved to treat HRF related with pulmonary hypertension, a serious condition that affects neonates.
  • Marketed as INOflo/INOvent®, it has been approved by the Japan’s Ministry of Health, Labour and Welfare (MHLW) to be used for the treatment of peri-operative pulmonary hypertension in conjunction with heart surgery in neonates throughout adulthood.

In neonates with HRF associated with pulmonary hypertension, the vasodilator has been found to improve oxygenation and to reduce the necessity for a very invasive surgical technique called extracorporeal membrane oxygenation (ECMO). The new clinical indications in both Australia and Japan increase INOmax’s use to wider patient’s clinical populations.

“The approval of INOmax in Australia and Japan for cardiovascular surgery represents a significant milestone for Mallinckrodt and INOmax,” said Tom Englese, General Manager, Mallinckrodt in a press release. “Worldwide, there is a tremendous need for therapies for patients undergoing cardiac surgery. We look forward to helping meet these needs while broadening our reach in global markets.”

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