▎WuXi AppTec Content Team Report

Today (November 5), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) stated thatTeva Pharmaceutical Industries Ltd.The 5.1 class new drug applicationDeutetrabenazine Sustained-Release TabletsThe listing application has been accepted. Public information shows that Deutetrabenazine is aVesicular Monoamine Transporter 2 (VMAT2) InhibitorDing Ben NaZineTheDeuterated Drugs, which has previously been approved in China for the treatment of Huntington's disease and tardive dyskinesia.This is the new sustained-release tablet formulation of the product being submitted for marketing approval in China.

Screenshot source:CDE Official Website

Huntington's disease (HD) is a rare and fatal neurodegenerative disorder,Due to the presence of involuntary movement disorders, it is also known as Huntington's chorea.The disease isThe hereditary, mutated HTT protein is neurotoxic, causing gradual damage and death to nerve cells in the brain, leading to increasingly severe degeneration in patients' cognitive and physical control abilities.

Public information shows,TevaCompany'sDeutetrabenazine Tablets (Austed)One of the earliest deuterated drugs developed, it was approved by the U.S. FDA in 2017.Treatment of "chorea symptoms" associated with Huntington's disease.

In terms of the mechanism of drug action,TetrabenazineIs a class of vesicular monoamine transporter 2 (VMAT2) inhibitors.It primarily exerts its pharmacological activity by reversibly inhibiting VMAT 2 in the central nervous system, thereby reducing the supply of monoamine compounds such as 5-hydroxytryptamine, dopamine, and norepinephrine.. A large number of past studies have proven the significance of VMAT as a drug treatment target for various neuropathological conditions.

In chemistry,DeuteriumTetrabenazineIs a derivative analog compound of tetrabenazine, with a tetrabenazine scaffold structure, in which six hydrogen atoms are replaced by deuterium atoms.The incorporation of deuterium slows down drug metabolism, thereby reducing the frequency of dosing.Compared with the parent compound tetrabenazine,Deutetrabenazine has a longer half-life and significantly improved pharmacokinetic characteristics.。

In China,Deutetrabenazine Tablets byObtained NMPA in 2020Approval，For the treatment of chorea associated with Huntington's disease (HD) and tardive dyskinesia (TD) in adults, and entered the medical insurance through national medical insurance negotiation in the same yearContents. In February 2024, Enhua Pharmaceuticals announced a collaboration with Teva, obtaining exclusive commercial rights for the product in mainland China.

The product declared for marketing this time isDeutetrabenazine Sustained-Release Tablets. According toTevaCompany official website,This extended-release tablet can be used to treat chorea associated with Huntington's disease and tardive dyskinesia in adults.

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Nov 5，2024, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c