TEL AVIV, Israel & PARSIPPANY, N.J.–(BUSINESS WIRE)– Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA),today announced results from the ARC-HD (Alternatives for Reducing Chorea in Huntington’s Disease) trial, an approximately 3-year open-label, single-arm, 2-cohort, multicenter extension study evaluating the safety and tolerability of long-term treatment with AUSTEDO® (deutetrabenazine) tablets for chorea associated with Huntington’s Disease (HD). The ARC-HD study was conducted by Teva in partnership with the Huntington Study Group (HSG).
ARC-HD results showed that treatment with AUSTEDO had a safety and tolerability profile comparable with the First-HD randomized, double-blind, placebo-controlled, 12-week study. In ARC-HD medication compliance rates were greater than 90% over the ~3 year open-label extension period. Over this full period, AUSTEDO improved and maintained chorea control in both the Rollover cohort and the Switch cohort, as measured by the Unified Huntington’s Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) score.1
“These data provide important insight into the long-term use of deutetrabenazine for the treatment of chorea associated with Huntington’s disease, which can have a significant functional impact on people’s lives,” said Samuel Frank, MD, Associate Professor of Neurology and Director of HDSA Center of Excellence at Beth Israel Deaconess Medical Center, Boston, and lead author of the study. “Results of this study add to the safety and tolerability profile and support deutetrabenazine as a treatment choice for this progressive condition. We are deeply grateful to the researchers, patients and their families who played an integral role in this study.”
The analysis included a total of 119 patients: 82 patients who completed the randomized, double-blind placebo-controlled First-HD trial (Rollover cohort), and 37 patients who converted overnight from a stable tetrabenazine dose to AUSTEDO with subsequent dose adjustments (Switch cohort). The average mean daily dose of AUSTEDO at the conclusion of the study was 45.7 mg. The findings were published online in CNS Drugs.
“Chorea is one of the most striking physical manifestations of Huntington’s Disease that occurs in approximately 90% of HD patients,” said Eran Harary, MD, SVP, Global Head of Specialty R&D at Teva. 2 “As a disease that can have significant functional impact on patients’ and caregivers’ lives, we’re proud to share these new data to provide valuable insights for this community of patients and for those who provide care to them each day.”