The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of chorea associated with Huntington’s disease, according to an announcement by the drug’s manufacturer, Teva Pharmaceutical.
The random, sudden, involuntary twisting and writhing movements of chorea constitute perhaps the most striking symptom of Huntington’s disease and affect about 90% of the roughly 35,000 Americans with the fatal neurodegenerative disorder. Deutetrabenazine is only the second product approved to treat Huntington’s in any capacity, and it is the first in nearly a decade.
The FDA’s approval was based on results from the First-HD trial , which assessed the safety and efficacy of deutetrabenazine in a phase III, randomized, placebo-controlled study.
The most common side effects of deutetrabenazine were somnolence, diarrhea, dry mouth, and fatigue. Deutetrabenazine is contraindicated in patients with hepatic impairment; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; patients taking reserpine or within 20 days of discontinuing reserpine; and patients taking tetrabenazine. Deutetrabenazine can cause worsening of mood and is not recommended for suicidal patients or patients with improperly treated depression.
“Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families. The FDA’s approval of Austedo represents an important new treatment option for people with HD and highlights the need for more therapeutic resources for this underserved patient community,” Louise Vetter, CEO of the Huntington’s Disease Society of America, said in the company’s announcement .
