FDA Rejects Deutetrabenazine for Treatment of Chorea Associated With Huntington Disease

Agency wants more information on metabolite levels

The FDA has issued a complete response letter regarding the new drug application for deutetrabenazine (SD-809, Teva Pharmaceutical Industries) for the treatment of chorea associated with Huntington disease (HD). The agency has asked Teva to examine blood levels of certain metabolites. No new clinical trials have been requested.

Deutetrabenazine is an investigational, oral, small-molecule inhibitor of vesicular monoamine 2 transporter (VMAT2) that is being developed for the treatment of chorea associated with HD. The treatment was granted an orphan drug designation for the treatment of HD by the FDA. Teva is also investigating the potential of deutetrabenazine for treating tardive dyskinesia (TD), for which the FDA has granted a breakthrough therapy designation, and for tics associated with Tourette syndrome (TS), for which the FDA has granted orphan status for pediatric use.

Deutetrabenazine uses Teva’s deuterium technology. It is the first deuterated product to be reviewed by the FDA.

HD is a rare and fatal neurodegenerative disorder caused by the death of nerve cells in the brain that affects approximately one in 7,000 to 10,000 people in western countries. Chorea—abnormal, involuntary writhing movements—is one of the physical manifestations of the disease, affecting approximately 90% of patients.

Teva is currently conducting a phase 3 trial of deutetrabenazine in patients with moderate-to-severe TD and expects data from this study later in 2016, with regulatory submission to follow. Deutetrabenazine has also been granted orphan drug status for the treatment of TS in pediatric patients (up to 16 years of age), and Teva is planning further evaluation of the drug as a treatment for tics associated with TS.

Source: Teva Pharmaceuticals; May 31, 2016.