US FDA approves Teva’s Austedo tablets to treat chorea associated with HD
Teva Pharmaceutical’s Austedo (deutetrabenazine) tablets have been approved by the US Food and Drug Administration (FDA) to treat chorea associated with Huntington’s disease (HD).
Austedo was previously granted orphan drug designation by the FDA.
HD is a rare and fatal neurodegenerative disorder that affects more than 35,000 people in the US.
One of the most striking physical manifestations of this disease is Chorea and occurs in about 90% of patients.
Teva Pharmaceutical global R&D president Michael Hayden 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 programme which supported the approval of austedo and our ongoing commitment to patients, we feel uniquely positioned to bring this treatment option forward.”
The approval was based on results from a Phase III study, which assessed the safety and efficacy of the tablets in reducing chorea in patients with HD (First-HD).
The efficacy of austedo was established in the randomised, placebo-controlled study, which involved 90 ambulatory patients with manifest chorea associated with HD.
Total maximal chorea scores for patients receiving the tablets improved by about 4.4 units from baseline to the maintenance period, compared to about 1.9 units in the placebo group.