FDA Advises Remedy Pharmaceuticals on Advancing CIRARA for Severe Stroke Treatment

NEW YORK, Nov. 19, 2024 - Remedy Pharmaceuticals, a prominent entity in the field of stroke drug development, announced the outcomes of a recent Type C meeting with the U.S. Food and Drug Administration (FDA) held on October 16, 2024. This meeting was crucial to gain feedback on the design of a Phase 3 trial for CIRARA, their investigational drug targeting large hemispheric infarction (LHI), a particularly severe and life-threatening form of ischemic stroke.

In the pharmaceutical industry, a Type C meeting is a structured discussion between the FDA and a sponsor, aimed at reviewing product development strategies. Remedy Pharmaceuticals sought the FDA's input on their proposed Phase 3 trial, and the meeting provided important clarifications on the trial's design through detailed minutes.

Sven Jacobson, the CEO of Remedy Pharmaceuticals, expressed optimism following the meeting, stating, "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. 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."

Large hemispheric infarctions (LHIs) are severe strokes that affect a substantial portion of one hemisphere of the brain, often involving the area supplied by the middle cerebral artery (MCA). These strokes can cause extensive brain damage and lead to serious complications, including severe cerebral edema, increased intracranial pressure, and potentially brain herniation.

Remedy Pharmaceuticals, based in New York, is a privately-owned clinical-stage pharmaceutical company. Their focus is on developing and delivering lifesaving treatments for individuals suffering from acute central nervous system (CNS) diseases and injuries.