US Food and Drug Administration grants Sanbexin sublingual tablets breakthrough therapy status

NANJING, China, 14 September 2024 /PRNewswire/ — On 2 September2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin sublingual tablets (edaravone and dexborneol sublingual tablets), an innovative anti-stroke drug, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of acute ischemic stroke (AIS). Sanbexin sublingual tablets are the first innovative drug in the world to receive Breakthrough Therapy Designation from the FDA for the treatment of stroke.

The breakthrough therapy designation comes from provisions of the Food and Drug Administration Safety and Innovation Act. It is intended to speed up the development and regulatory review of drugs to treat serious diseases and address significant medical problems. The designation will help the drugs receive FDA guidance for clinical development, speed up the clinical development process overseas, and also significantly reduce the time for market approval review through the Priority Review designation.

The title “Breakthrough Therapy” is based on the significant improvement in efficacy metrics demonstrated by the sublingual tablets in a previous clinical trial. The data from a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial in China for the treatment of AIS showed that Sanbexin sublingual tablets significantly improved neurological recovery and independent living ability in patients with AIS compared to placebo and met the expected efficacy endpoints with a favorable safety profile. JAMA Neurology has published the key results of the study online.

The designation will be beneficial to Simcere as it will obtain FDA guidance for the clinical development of Sanbexin sublingual tablets, accelerate the clinical development process overseas, and is also expected to significantly shorten the time for market approval review through the Priority Review designation.

According to a recent article in The Lancet, stroke is the second leading cause of death and disability worldwide. Every year, 12 million new cases and 6.6 million deaths occur. Acute ischemic stroke is the most common type of stroke, accounting for approximately 70% of all strokes and representing a heavy burden of disease in all countries of the world. The effectiveness of treatment for acute ischemic stroke is highly dependent on time. Treating as early as possible helps patients improve their disease course and avoid disability.

Sanbexin sublingual tablets are a brain cytoprotective agent composed of edaravone and dexborneol, two active ingredients with synergistic antioxidant and anti-inflammatory effects that can significantly reduce brain cell damage or impairment caused by AIS. This unique sublingual formulation can dissolve quickly upon contact with saliva when placed under the tongue and can be absorbed into the blood through the sublingual venous plexus, which is intended to increase the flexibility of stroke treatment. Sequential therapy consisting of the commercially available Sanbexin concentrated injection solution. These two formulas allow patients to receive complete treatment in and out of the hospital.

To 28 June 2023the New Drug Application (NDA) for Sanbexin sublingual tablets in China is accepted by the National Medical Products Administration. The first indication is the improvement of neurological symptoms, daily activities and functional impairment due to AIS. Phase I clinical trials for Sanbexin sublingual tablets in healthy volunteers were conducted in the United States.

CONTACT: Haoyun Huang, [email protected]

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