FDA Approves Treatment for Huntington's Disease

Patients with chorea associated with Huntington’s disease have the first new treatment in nearly a decade to treat their chorea. The FDA has approved Teva Pharmaceutical Industries Ltd’s Austedo (deutetrabenazine) for the treatment of chorea. Lundbeck’s Xenazine is the only other drug approved to treat chorea.

Chorea is an involuntary, random and sudden, twisting or writhing movements and is a major symptom for patients with Huntington’s. Approximately 90% of patients with Huntington’s suffer from this symptom.

“It impacts patients’ functionality and activities of daily living, and there have been limited treatment options for these patients,” Michael Hayden, MD, PhD, president of Global R&D and chief scientific officer at Teva, said in a statement. “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.”

Austedo was approved based on results from a phase 3 study that assessed safety and efficacy of reducing chorea. The study found that among 90 patients who were randomized to receive either placebo or Austedo, that Teva’s drug improved Total Maximal Chorea Scores by approximately 4.4 units from baseline to the maintenance period compared with an increase of 1.9 units in the placebo group.

The drug has a safety warning for depression and suicidality. According to the safety information, Austedo can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. As a result, Austedo is contraindicated in patients who are suicidal or who have untreated or inadequately treated depression.

“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. She added that the approval of Austedo represents a new option for people with the disease and “highlights the need for more therapeutic resources for this underserved patient community.”