NEW YORK, Oct. 22, 2024 /PRNewswire/ -- Remedy Pharmaceuticals, a pioneer in stroke drug development, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Division (OOPD) has granted Orphan Drug Designation 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 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,” said Sven Jacobson, CEO of Remedy Pharmaceuticals. “This designation will accelerate our efforts to bring CIRARA to acute ischemic stroke patients at the highest risk of severe disability and death.”
The FDA’s Orphan Drug Designation program provides orphan status to drugs or biologics intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. Sponsors of medicines with Orphan Drug Designation may be eligible for various incentives, including tax credits for qualified clinical trials, prescription drug user fee exemptions, and seven years of marketing exclusivity upon FDA approval.
About Large Hemispheric Infarction
A large hemispheric infarction is a particularly severe type of ischemic stroke that affects a substantial portion of the brain. This occurs when there is a blockage in a major cerebral artery, such as the middle cerebral artery (MCA) or the internal carotid artery (ICA), both of which are responsible for supplying large regions of the brain with oxygen-rich blood.
Treatment for LHI typically involves rapid revascularization strategies to restore blood flow, such as mechanical thrombectomy or intravenous thrombolysis (administering clot-dissolving drugs like tPA). However, the large scale of the infarction and the resultant edema leads to poorer outcomes compared to smaller strokes, with many patients suffering long-term disability or, in some cases, death.
About Remedy Pharmaceuticals:
New York-based Remedy Pharmaceuticals, Inc. is a privately held, clinical-stage pharmaceutical company focused on developing and bringing lifesaving treatments to people affected by acute central nervous system (CNS) diseases and injuries.
Contact:
Sven Jacobson
CEO
Remedy Pharmaceuticals
212.586.2226
sven@remedypharmaceuticals.com
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SOURCE Remedy Pharmaceuticals
