Ikaria Receives Orphan Drug Status for Inhaled Carbon Monoxide

The FDA has granted orphan drug designation to Ikaria for its inhaled carbon monoxide in reducing the incidence and severity of delayed graft function (DGF) in patients receiving organ transplants.

DGF occurs when a kidney does not function sufficiently after a transplant. The underlying cause is ischemia-reperfusion injury, which occurs when blood flow is returned to damaged tissue, leading to an inflammatory response that could result in poor organ function.

Preclinical data has shown that the compound may possess anti-inflammatory, cytoprotective and anti-apoptotic properties that could potentially improve ischemic-reperfusion mediated malfunction in transplanted organs, Ikaria said.