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Deutetrabenazine is the first deuterated product approved by FDA, approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a decade.
Teva Pharmaceutical announced that FDA has approved Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease. The drug, previously known as SD-809 during the development stage, marks the first deuterated product approved by FDA and the second product approved for treating Huntington’s disease. Deutetrabenazine was previously granted orphan drug designation by FDA.
Huntington’s disease is a rare and fatal neurodegenerative disorder that affects more than 35,000 people in the United States. One of the symptoms of the disease is chorea (i.e., involuntary, random, and sudden twisting and/or writhing movements) and it occurs in approximately 90% of patients.
The approval of Austedo by FDA was based on results from a Phase III randomized, placebo-controlled study evaluating the safety and efficacy of Austedo in reducing chorea in patients with Huntington’s disease. The efficacy of the drug as a treatment for chorea associated with Huntington's disease was established in a randomized, double-blind, 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 with approximately 1.9 units in the placebo group. The treatment effect was statistically significant (p<0.0001). The maintenance endpoint is the mean of the total maximal chorea scores for the Week 9 and Week 12 visits. At the Week 13 follow-up visit (one week after discontinuation of the study medication), the total maximal chorea scores of patients who had received Austedo returned to baseline.