Teva's Rare Disease Drug Deutetrabenazine Submitted for Market Approval in China

Original: winter

On December 27, the Center for Drug Evaluation (CDE) accepted Teva’s marketing application for Deutetrabenazine Tablets in China, for the treatment of Huntington’s disease, a rare autosomal dominant genetic disorder.

Deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor developed by Teva, was approved by the FDA in 2017 for the treatment of Huntington's chorea, becoming the first deuterated drug to be marketed worldwide.

Deutetrabenazine is a derivative of tetrabenazine, in which the six hydrogen atoms (H) of the two methoxy groups on the benzene ring are replaced by deuterium atoms (D). The incorporation of deuterium slows drug metabolism, reduces dosing frequency, and significantly enhances the safety and efficacy of the medication.

Huntington's chorea is a rare autosomal dominant genetic disorder for which there are currently no effective treatments. Clinical studies have demonstrated that deutetrabenazine has clear therapeutic efficacy in the treatment of Huntington's chorea.

In China, this drug was included in the first batch of clinically urgent overseas new drugs published by the national authorities in November 2018. In line with the national emphasis on rare disease medications, the review process for such drugs in China has been continuously accelerated. The rare disease drug “Agalsidase Beta for Injection,” approved on December 19, underwent a marketing application review that took only 14 months. It is anticipated that deutetrabenazine will soon enter the Chinese market, providing a new therapeutic option for patients with Huntington’s disease.

The figure below is from the Insight database - Urgently Needed Overseas New Drugs for Clinical Use (https://db.dxy.cn)

Original Title: Deutetrabenazine Tablets for the Treatment of Huntington's Disease Submitted for Market Approval in China