The FDA has approved Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease. The drug has previously been referred to as SD-809 by its developers, Teva Pharmaceuticals.
Last year, Teva received a Complete Response Letter from the FDA regarding SD-809 but based on the approval today, the FDA and the company have worked out their differences.
The FDA approval was based on results from a Phase III randomized, placebo-controlled study testing the safety and efficacy of deutetrabenazine in reducing chorea in patients with Huntingon’s disease. In the study, 90 ambulatory patients with chorea associated with Huntington’s disease were randomized to receive deutetrabenazine or placebo. The study found that deutetrabenazine improved Total Maximal Chorea Scores by approximately 4.4 units from baseline to the maintenance period (average of Week 9 and Week 12), compared to an increase of 1.9 units in the placebo group (P < .0001).
The only other drug approved for the treatment of chorea in Huntington’s disease is Xenazine (tetrabenazine) by Lundbeck. The new drug by Teva is a deuteriated version of tetrabenazine.
Last year, we talked with Samuel Franks, MD of Beth Israel Deaconess Medical Center about the efficacy of SD-809 to treat chorea and dystonia in patients with Huntington's disease. Click the image below to watch a clip from that interview.
Warning: Depression and Suicidal Thoughts
The newly approved drug will come with a warning that “Austedo can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of Austedo must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Austedo is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.”
Huntington's Disease is an inherited brain disorder that results in the progressive loss of both mental and motor control. Symptoms usually appear between the ages of 30 to 50, and worsen over a 10 to 25-year period until the patient eventually dies. Chorea is the pronounced symptom of the condition.