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.”
Ikaria expects that INOmax will be marketed and distributed in Australia from January 2008 onwards, through an alliance with BOC Medical, a company within The Linde Group. This is seen as important to the company, as Shaw notes, “Through our partner BOC Medical, with its 60 years of experience in Australia, we look forward to bringing this important therapy to neonatal critical care across the Australian continent.”
INOmax is also approved as a pharmaceutical gas in the US, Europe, Canada, Singapore and several countries in Latin America.