Ikaria Holdings Inc, through its subsidiary INO Therapeutics LLC, has received approval from Australia’s regulatory body, the Therapeutic Goods Administration (TGA), for INOmax nitric oxide for inhalation and the gas becomes the first pharmaceutical gas to be approved in Australia.
INOmax has been designated an orphan drug by the TGA, providing a pathway for the development of the product to treat rare disorders. INOmax is indicated for the treatment of near and full-term newborn babies who suffer from hypoxic respiratory failure (HRF), a potentially life-threatening condition that prevents babies’ lungs from delivering enough oxygen to their bodies.
The approved gas is designed to help critically ill newborns breathe more effectively by dilating the blood vessels of the lungs and improve both oxygen uptake and oxygen supply to the tissues of the body. As well as proving an effective remedy, INOmax therapy has been shown to reduce the need for a highly invasive surgical procedure known as ECMO (extracorporeal membrane oxygenation), during which an infant’s blood is mechanically oxygenated through a heart-lung machine.
David Shaw, Ikaria chairman and CEO, commented, “As we broaden the reach of INOmax to new continents, we are expanding our ability to advance critical care around the globe.”
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