US regulators have green-lighted Teva Pharmaceutical Industries’ Austedo for the treatment of chorea associated with Huntington’s disease (HD), offering patients the first new treatment option in nearly a decade.
A rare and fatal neurodegenerative disorder, HD affects more than 35,000 people in the US. Chorea - involuntary, random and sudden, twisting and/or writhing movements - is a key physical manifestation of this disease occurring in around 90 percent of patients.
Austedo (deutetrabenazine; SD-809) is an investigational, oral, small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is designed to regulate the levels of a specific neurotransmitter, dopamine, in the brain.
In clinical trials, the total maximal chorea scores for patients receiving Teva’s drug improved by around 4.4 units from baseline to the maintenance period (average of Week 9 and Week 12), compared to approximately 1.9 units in the placebo arm.
“Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families,” said Louise Vetter, chief executive 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 drug, which was picked up by Teva through its purchase of Auspex and is now the first deuterated product to be approved by the FDA, is also currently under a priority review for the rare hyperkinetic movement disorder tardive dyskinesia.