FDA Grants Orphan Drug Designation to Remedy Pharma's CIRARA for Treatment of Acute Ischemic Stroke

Remedy Pharmaceuticals, a pioneer in stroke drug development, has announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Division (OOPD) has granted Orphan Drug Designation to CIRARA for treating large territory acute ischemic stroke, including large hemispheric infarctions (LHI). According to Sven Jacobson, CEO of Remedy Pharmaceuticals, this designation highlights the unique mechanisms and universally poor outcomes of large territory ischemic strokes compared to smaller strokes.

Publish Date: 22-10-2024 Source: Remedy Pharmaceuticals

Acute ischemic stroke (AIS) occurs when a blood vessel supplying the brain becomes obstructed, resulting in a significant reduction or cessation of blood flow to the affected area. Stroke stands as one of the foremost contributors to mortality and disability across the globe. Modifiable risk factors encompass a range of health conditions and lifestyle factors that individuals have the potential to influence. These include hypertension, diabetes mellitus, cardiac disease, elevated cholesterol levels, prior stroke history, carotid artery stenosis, and hyperhomocysteinemia. The obstruction of cerebral blood flow precipitates the onset of acute ischemic stroke, where the prognosis is notably influenced by the time elapsed since symptom onset. At the cellular level, the abrupt cessation of blood flow due to a blood clot (thrombus) or plaque (fatty deposits) disrupts the delivery of essential nutrients and oxygen to brain tissue, leading to irreversible damage. Ischemic stroke triggers mitochondrial cell death, exacerbating tissue injury. Computed tomography (CT) of the brain is typically the initial imaging modality employed for stroke detection. Widely accessible in hospital settings, CT scans offer rapid results and enable the identification of intracranial hemorrhage, necessitating distinct treatment approaches from acute ischemic stroke. Brain magnetic resonance imaging (MRI) is also frequently utilized for diagnosing acute ischemic stroke. In AIS management, tissue plasminogen activator (tPA) represents the gold standard treatment associated with enhanced patient clinical outcomes. Administering intravenous tPA promptly following the onset of stroke symptoms correlates with improved prognosis, underscoring the importance of timely intervention in AIS management.

However, the current Acute Ischemic Stroke treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Ticagrelor, Glenzocimab (ACT017), Nerinetide, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Acute Ischemic Stroke treatment. The key companies in the advanced development stage are AstraZeneca, Acticor Biotech, NoNO Inc., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Acute Ischemic Stroke to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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