Remedy Pharmaceuticals Receives FDA Guidance to Advance CIRARA for Treatment of Severe Stroke
NEW YORK, November 19, 2024 – Remedy Pharmaceuticals, a leader in stroke drug development, announced today that a Type C meeting held with the U.S. Food and Drug Administration (FDA) on October 16, 2024, provided valuable feedback on the design of a Phase 3 trial of its investigational drug, CIRARA, for large hemispheric infarction (LHI), a severe and life-threatening form of ischemic stroke.
A Type C meeting is a formal discussion between the FDA and a sponsor to review product development plans. Remedy sought feedback on the proposed Phase 3 study, and the meeting, along with meeting minutes, clarified key aspects of the trial’s design.
“The FDA’s feedback reinforces our confidence in our planned Phase 3 trial design and CIRARA’s potential to address the urgent unmet needs of patients with LHI,” said Sven Jacobson, CEO of Remedy Pharmaceuticals. “We are committed to advancing CIRARA and to redefining the standard of care for this devastating condition characterized by high mortality and severe long-term disability.”
About Large Hemispheric Infarctions
Large hemispheric infarctions (LHIs) are severe strokes affecting a significant portion of one cerebral hemisphere, typically involving the territory supplied by the middle cerebral artery (MCA). These strokes result in extensive brain damage and often lead to life-threatening complications such as severe cerebral edema, increased intracranial pressure, and brain herniation.
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