Teva to Present New Data Supporting Real-World Effectiveness of Austedo in Huntington Disease

Rare Daily Staff

Teva Pharmaceutical last week reported positive new interim results from a phase 4 study of its drug Austedo in people with Huntington disease at the Huntington Study Group Annual Meeting.

Huntington Disease (HD) is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. Chorea – involuntary, random, and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of Huntington disease and occurs in approximately 90 percent of patients. Chorea can have a significant impact on daily activities and progressively limit peoples’ lives.

Austedo XR and AUSTEDO are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington disease. Safety and effectiveness in pediatric patients have not been established. AUSTEDO XR is the once-daily formulation of AUSTEDO.

Interim results from the 17 patients enrolled in the HD cohort of the START trial, a phase 4 study investigating real-world use of Austedo with a four-week patient titration kit along with treatment success as measured at the end of treatment.

The study showed that by week 12, 50 percent of patients achieved treatment success as assessed by the Clinical Global Impression of Change (CGIC) and 63 percent as assessed by the Patient Global Impression of Change.

There was a 41 percent mean reduction in total maximal chorea score from baseline, and 71 percent of patients successfully completed the titration kit, with adherence averaging 91 percent. All of the patients who completed the satisfaction survey found the kit easy to use.

“With 90 percent of HD patients developing chorea, it’s critical that treatment options can address the unmet needs of this community,” said Karen Anderson, professor of Psychiatry and Neurology at Georgetown University School of Medicine and director of Huntington Disease Care, Education and Research Center. “These data reinforce that in real-world settings the Austedo 4-week Patient Titration Kit enabled patients to titrate to therapeutic Austedo doses with satisfaction, adherence, and effectiveness similar to results demonstrated in the pivotal clinical trials.”