Teva’s New Treatment for Huntington’s Disease Approved by FDA

Teva Pharmaceuticals’ Huntington’s Disease drug, Austedo (deutetrabenazine), has been approved by the FDA in the treatment of involuntary movements associated with the disorder, known as chorea. According to a press release issued by the company, it’s been nearly ten years since a new drug for chorea associated with Huntington’s disease has been approved by the regulator.

“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 Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva. “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.”

Huntington’s disease is a rare and often fatal neurodegenerative disorder which affects over 35,000 patients in the US. Around 90 percent of these patients experience symptoms of chorea, including sudden and involuntary twisting and writhing movements.

The results from two Phase III clinical trials – FIRST-HD and ARC-HD – were used to support the FDA’s decision to approve Austedo. The FIRST-HD study provided evidence that Austedo was able to reduce chorea in patients, compared to a placebo. Patients who were taking tetrabenazine, the only other FDA approved treatment for chorea, were able switch to Austedo without losing symptom control, in the ARC-HD clinical trial.

“Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families,” said Louise Vetter, CEO 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.”

Austedo is a small molecule drug designed to regulate neuronal levels of dopamine. The drug does carry a warning that Austedo can increased the risk of depression and suicidal ideation in patients with Huntington’s disease, which could limit its use.

Teva added Austedo to their portfolio after the 2015 acquisition of Auspex Pharmaceuticals. The FDA granted Orphan Drug Designation to Austedo in late 2014.