The first deuterated new drug Austedo, approved for listing in China

On December 27, 2019, the deuterated tetrabenazine tablets from Teva directly submitted a new drug marketing application (NDA) in China, and was accepted by CDE to accept the public notice. This product submits relevant materials in accordance with the "Clinical Urgent Needs for Review and Approval Procedures for Overseas New Drugs", and directly submits a marketing application. Previously, deuterated tetrabenazine tablets were included in the list of CDE's first batch of clinically-needed overseas new drugs. On March 13, 2020, CDE announced that the application of deuterated tetrabenazine tablets for marketing should be included in the priority review process according to the priority review scope (1). 3 drugs with obvious therapeutic advantages. According to the data of the medicine melting circle, this product was approved for listing in China on May 12, 2020.

On April 3, 2017, the world's first deuterated drug -Austedo ™ (deutetrabenazine, deuterated tetrabenazine tablets) was approved by the US FDA for the treatment of abnormal involuntary movements caused by Huntington's disease. Austedo ™ is a small molecule oral inhibitor targeting VMAT-2 (vesicular monoamine transporter 2). Huntington ’s Disease is a rare autosomal dominant genetic disease, and there is currently no effective treatment. The specific mechanism of action is unknown, but it is believed to be related to its reversible monoamine depletion. In addition, this product is also approved by the FDA for use in adults with tardive dyskinesia.