The government has granted the nod to go ahead with phase-3 trials on deutetrabenazine (brand name: Austedo in the U.S.), a new treatment for Huntington’s chorea developed by Teva, to check its efficacy for Tourette syndrome.
The Ministry of Food and Drug Safety gave approval for phase-3 trials on Feb. 7 and Feb. 27, respectively, to evaluate whether the drug works on the neurodevelopmental disorder.
Teva developed deutetrabenazine as a treatment for Huntington’s disease, an inherited disorder that results in the death of brain cells. The company is working to develop the drug to treat Tourette syndrome as well.
The U.S. approved deutetrabenazine as Huntington’s chorea treatment in 2017.
In Korea, Teva Handok is preparing to roll it out.
The phase-3 study approved on Feb. 27 is an open, long-term, double-blind, and placebo-controlled safety trial that includes randomized drug withdrawal to test TEV-50717 (deutetrabenazine) for the treatment of Tourette syndrome in pediatric patients.
The global study will be on 212 patients including 10 Koreans at Seoul Hospital, Seoul National University Hospital, Severance Hospital, and Asan Medical Center.
The other trial, approved on Feb. 7, is a well-controlled, fixed-dose trial of TEV-50717 for the treatment of Tourette syndrome-related tics. The study will be on 150 patients around the world including 15 in Korea.
Developed in more than a decade, deutetrabenazine obtained the FDA approval as an orphan drug for Huntington’s chorea in 2017.
Huntington's disease is a rare neurodegenerative disease. One of the typical symptoms is abnormal motor symptoms such as sudden twisting and jerking. This is called chorea because it occurs regardless of the patient’s will, and it occurs in about 90 percent of patients with Huntington’s disease.
<© Korea Biomedical Review, All rights reserved.>