Teva Pharmaceutical’s deutetrabenazine has been given the green light by the U.S. Food and Drug Administration for the treatment of chorea associated with Huntington’s disease. Chorea refers to an abnormal involuntary movement disorder, one of a group of neurological disorders called dyskinesias, and is characterized by brief, semi-directed, irregular movements that are not repetitive or rhythmic, but appear to flow from one muscle to the next.
Deutetrabenazine, marketed as AUSTEDO, the first deuterated product approved by the FDA, was previously granted Orphan Drug Designation by the FDA. Chorea is one of the most striking physical manifestations of Huntington’s disease and occurs in approximately 90% of patients.
Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva, said:
“Chorea is a major symptom for many living with Huntington disease. It impacts patients’ functionality and activities of daily living, and there have been limited treatment options for these patients. Based on the results demonstrated in the clinical development program which supported the approval of AUSTEDO and our ongoing commitment to patients, we feel uniquely positioned to bring this treatment option forward.”
Huntington’s disease (HD) is caused by degeneration of cells in the brain, the neurons, as a result of genetic changes. The symptoms of this disease that runs in families first become apparent in middle age, and it progresses over 15 to 20 years before leading to an inevitable death. Both the speed at which the disease progresses and the age of onset varies from one person to another.
The FDA approval of deutetrabenazine tablets was based on results from a Phase III randomized, placebo-controlled clinical trial to assess the safety and efficacy of AUSTEDO in reducing chorea in patients with HD (First-HD). Deutetrabenazine is an analog of tetrabenazine in which six hydrogen atoms have been replaced by deuterium atoms. The incorporation of deuterium slows the rate of drug metabolism, allowing less frequent dosing.