FDA recently approved deutetrabenazine (Austedo, Teva Pharmaceuticals) to treat chorea associated with Huntington’s disease (HD). The medication is only the second product approved to treat HD, and is the first deuterated product approved by FDA.
A rare and fatal neurodegenerative disorder, HD affects more than 35,000 people in the United States. Chorea—iinvoluntary, random and sudden, twisting and/or writhing movements—is one of the most striking physical manifestations of this disease and occurs in approximately 90% of patients.
Related: HIV dual therapy shows promise
Teva expects the drug to be available to patients by the end of April.
“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,” said Michael Hayden, MD, PhD, president of Global R&D and chief scientific officer at Teva, in a statement from the company. “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.”
"Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families,” said Louise Vetter, CEP of the Huntington’s Disease Society of America, in the Teva statement. “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.”
The approval was based on results from a phase 3 randomized, placebo-controlled, multicenter trial conducted in 90 ambulatory patients with manifest chorea associated with Huntington’s disease. Total Maximal Chorea Scores for patients receiving Austedo improved by approximately 4.4 units from baseline to the maintenance period (average of Week 9 and Week 12), compared to approximately 1.9 units in the placebo group. The treatment effect of -2.5 units was statistically significant.
Read more: New Parkinson's drug, 2 others approved