Simcere Pharmaceuticals Group Ltd. announced that its Sanbexin sublingual tablets (edaravone and dexborneol) have been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute ischemic stroke (AIS). This marks Sanbexin as the first innovative drug globally to receive this designation from the FDA for stroke treatment.
The Breakthrough Therapy designation, stemming from the Food and Drug Administration Safety and Innovation Act, aims to accelerate the development and review of drugs targeting serious conditions with unmet medical needs. It provides companies with increased FDA support in clinical development, potentially expediting the clinical development process and marketing approval timelines.
This designation was supported by efficacy data from a Phase III clinical trial conducted in China. The multi-center, randomized, double-blind, placebo-controlled study demonstrated that Sanbexin sublingual tablets significantly improved neurological recovery and the ability to perform activities of daily living in AIS patients compared to placebo. The study met its pre-specified efficacy endpoints while maintaining a favorable safety profile. Key results from the study have been published in JAMA Neurology.
According to an article in The Lancet, stroke is the second leading cause of death and disability worldwide, with 12 million new cases and 6.6 million deaths annually. Acute ischemic stroke accounts for approximately 70% of all strokes, representing a significant global health burden. Timely treatment is critical in AIS to improve patient outcomes and reduce disability.
Sanbexin sublingual tablets combine edaravone and dexborneol, offering synergistic antioxidant and anti-inflammatory effects to protect brain cells from damage caused by AIS. The sublingual formulation allows for rapid absorption into the bloodstream, potentially increasing the flexibility of stroke treatment. This formulation is designed to be used sequentially with Sanbexin injection, allowing for comprehensive treatment both inside and outside of the hospital setting.
The New Drug Application (NDA) for Sanbexin sublingual tablets was accepted in China on June 28, 2023, for improving neurological symptoms, daily activities, and functional impairment due to AIS. Phase I clinical trials for Sanbexin sublingual tablets have been completed in healthy subjects in the United States.
