Simcere Pharmaceuticals Group Ltd. (2096.HK) has announced that its innovative Sanbexin Sublingual Tablets, a drug designed for the treatment of Acute Ischemic Stroke (AIS), has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA). This marks the first time a drug for stroke has achieved this designation.
The FDA’s Breakthrough Therapy designation, established under the “Food and Drug Administration Safety and Innovation Act,” aims to expedite the development and regulatory review process for drugs targeting serious conditions with significant unmet needs. This designation will facilitate FDA guidance during clinical development and accelerate the clinical development timeline, potentially shortening the marketing review process through priority review.
Sanbexin Sublingual Tablets, a novel formulation combining edaravone and dexborneol, have demonstrated significant improvements in efficacy metrics in clinical studies. A multicenter, randomized, double-blind, parallel, placebo-controlled Phase III trial in China showed that the tablets notably enhanced neurological recovery and independent living abilities in AIS patients compared to a placebo, while maintaining a favorable safety profile. These findings were published online in JAMA Neurology.
The designation is expected to aid Simcere in securing FDA guidance and expediting the drug’s international clinical development and review process.
Stroke, particularly acute ischemic stroke, poses a substantial global health burden. According to 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 stroke cases. Timely treatment is critical for improving patient outcomes and reducing disability.
Sanbexin Sublingual Tablets offer a novel approach as a brain cytoprotective agent. The tablets, which quickly dissolve under the tongue, are designed for rapid absorption into the bloodstream via the sublingual venous plexus. This unique formulation aims to enhance the flexibility of stroke treatment, complementing the existing Sanbexin concentrated solution for Injection, allowing for a comprehensive treatment approach both in and out of hospital settings.
In addition to the FDA designation, the New Drug Application (NDA) for Sanbexin Sublingual Tablets was accepted by the National Medical Products Administration in China on June 28, 2023. The initial indication for the drug is to improve neurological symptoms, daily activities, and functional impairment caused by AIS. Phase I clinical trials in the U.S. on healthy volunteers have been completed, further supporting the drug’s development.
