NANJING, China, Sept. 16, 2024 /PRNewswire/ — On September 2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that sanbexin sublingual tablets (edaravone and dexborneol sublingual tablets), an innovative stroke medicine, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of ischemic stroke. Sanbexin sublingual tablets are the world’s first innovative medicine to be designated by the FDA as a Breakthrough Therapy for the treatment of stroke.
Breakthrough Therapy designation for Sanbexin sublingual tablets
Breakthrough therapy designation is a product of the Food and Drug Administration Safety and Innovation Act and is designed to expedite the development and regulatory review of drugs that treat serious diseases and address significant unmet medical needs. This designation allows drugs to obtain FDA guidance on clinical development, expedites the process of clinical development abroad, and is also expected to significantly reduce the time to market review through the Priority Review designation.
Breakthrough Therapy designation is based on the significant improvement in efficacy parameters demonstrated by sublingual tablets in a clinical study. Data from a multicenter, randomized, double-blind, parallel, placebo-controlled phase III clinical study conducted in China for the treatment of ischemic stroke demonstrated that sanbexin sublingual tablets significantly improved neurological recovery and independent functioning in patients with ischemic stroke compared to placebo, meeting expected efficacy criteria with a favorable safety profile. JAMA Neurology published the primary results of the study online.
This designation will enable Simcere to obtain FDA guidance for the clinical development of sanbexin sublingual tablets, accelerate the overseas clinical development process and significantly shorten the market review timeline through Priority Review designation.
Sanbexin sublingual tablets are a brain cytoprotective agent composed of edaravone and dexborneol, two active ingredients with synergistic antioxidant and anti-inflammatory effects, which can significantly reduce brain cell damage or impairment caused by ischemic stroke. This unique sublingual formulation rapidly disintegrates upon contact with saliva once placed under the tongue and can be absorbed into the bloodstream through the sublingual venous plexus, which is expected to increase the flexibility of stroke treatment. Sequential treatment consisting of the marketed sanbexin injection concentrate solution. These two formulations allow patients to receive comprehensive treatment both in and out of hospital.
On June 28, 2023, the New Drug Application (NDA) for sanbexin sublingual tablets in China is accepted by the National Medical Products Administration. The first indication is for the improvement of neurological symptoms, daily activities, and functional impairment due to ischemic stroke. Phase I trials for sanbexin sublingual tablets in healthy volunteers have been completed in the United States.
CONTACT : Haoyun Huang, [email protected]
Photo – https://mma.prnewswire.com/media/2505695/Breakthrough_Therapy_designation_Sanbexin_sublingual_tablets.jpg
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