New York-based clinical-stage pharmaceutical company Remedy Pharmaceuticals announced on Tuesday that it has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for CIRARA for the treatment of 'large territory acute ischemic stroke', which includes large hemispheric infarctions (LHI).
LHI is a particularly severe form of ischemic stroke caused by a blockage in the one of two large blood vessels in the brain -- internal carotid artery or middle cerebral artery (MCA) -- which cuts off the blood supply to large areas of the brain, resulting in severe swelling, significant mortality, and high disability rates.
The FDA's Orphan Drug Designation program grants orphan status to drugs or biologics aimed at treating diseases or conditions that impact fewer than 200,000 people in the United States.
Sven Jacobson, Remedy Pharmaceuticals CEO, said: "The Orphan Drug Designation for CIRARA underscores the uniqueness of large territory ischemic strokes in terms of mechanism and universally poor outcomes in contrast to smaller strokes. This designation will accelerate our efforts to bring CIRARA to acute ischemic stroke patients at the highest risk of severe disability and death."
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