The U.S. Food and Drug Administration approved Austedo™(deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease (HD), Teva Pharmaceutical Industries said Wednesday.
Previously referred to by the developmental name SD-809, Austedo™ is the first deuterated product approved by the FDA and only the second product approved in HD, the Jerusalem-based drugmaker said. Approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a decade, it added.
HD is a rare and fatal neurodegenerative disorder and affects more than 35,000 people in the United States. Chorea- involuntary, sudden and random, twisting or writhing movements- is one of the most physical displays of this disease and it occurs in 90 percent of patients.
“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, chief scientific officer at Teva.
He went on to say, “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.”
An outside expert acknowledged its efficacy. “Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families,” said Louise Vetter, Chief Executive Officer of the Huntington’s Disease Society of America. “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 effectiveness of Austedo™ as a treatment for chorea associated with HD was established in a randomized, double-blind, placebo-controlled, multicenter trial conducted in 90 ambulatory patients with manifest chorea associated with Huntington’s disease.
Austedo™ can increase the risk of depression, suicidal thoughts, and behavior in patients with HD. VMAT2 inhibitors, including Austedo,™ may cause a worsening in mood, cognition, rigidity, and functional capacity and may increase the risk of akathisia, agitation, restlessness and may cause parkinsonism in patients with HD. Sedation is a common dose-limiting adverse reaction of Austedo™.
Austedo™ is expected to be available in the U.S. within the next three weeks.