Simcere Pharmaceuticals Group Ltd. announced that 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 ischemic stroke. This marks Sanbexin as the first innovative drug globally to receive this designation for stroke treatment.
The Breakthrough Therapy designation, established under the Food and Drug Administration Safety and Innovation Act, is designed to accelerate the development and regulatory review of drugs intended to treat serious conditions where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. This designation provides Simcere with increased access to FDA guidance on clinical development, potentially expediting the clinical development process and reducing the time required for marketing approval through priority review.
The designation was supported by data from a Phase III multicenter, randomized, double-blind, placebo-controlled clinical trial conducted in China. The study demonstrated that Sanbexin sublingual tablets significantly improved neurological recovery and the ability to perform activities of daily living in patients with ischemic stroke compared to placebo, meeting pre-specified efficacy criteria with a favorable safety profile. The primary results of the study were published online in JAMA Neurology.
Addressing a Critical Need in Stroke Treatment
Stroke is a leading cause of death and disability worldwide, with ischemic stroke accounting for approximately 70% of all stroke cases. According to a recent article in The Lancet, stroke affects 12 million new individuals and causes 6.6 million deaths annually. The effectiveness of ischemic stroke treatment is highly time-dependent, with earlier intervention leading to improved outcomes and reduced disability.
Mechanism of Action and Formulation
Sanbexin sublingual tablets contain edaravone and dexborneol, two active ingredients with synergistic antioxidant and anti-inflammatory effects. These components work to reduce brain cell damage or deficits caused by ischemic stroke. The sublingual formulation allows the drug to rapidly disintegrate upon contact with saliva and be absorbed into the bloodstream via the sublingual venous plexus, potentially increasing treatment flexibility. Sanbexin is also available as a concentrated injection solution, providing a comprehensive treatment option for patients both in and out of the hospital setting.
Regulatory Status and Future Development
The New Drug Application (NDA) for Sanbexin sublingual tablets was accepted in China by the National Medical Products Administration on June 28, 2023, for improving neurological symptoms, daily activities, and functional impairment due to ischemic stroke. Phase I trials of Sanbexin sublingual tablets in healthy volunteers have been completed in the United States. This Breakthrough Therapy designation will allow Simcere to obtain FDA guidance on the clinical development of Sanbexin sublingual tablets, accelerate the overseas clinical development process, and significantly shorten the marketing review time through priority review designation.
