Teva's New Real-World Evidence Presented At The 2024 AAN Annual Meeting Confirms Effectiveness And Patient Satisfaction For HD Chorea With The 4-week Titration Kit For AUSTEDO Tablets

Author: Benzinga Newsdesk | April 16, 2024 08:18am

• Almost 80% of patients with Huntington's disease (HD) chorea were able to achieve optimal dosing within four weeks with the 4-week Titration Kit in final START study results
• START study results further support real-world effectiveness, safety, adherence and patient satisfaction with the 4-week Titration Kit for AUSTEDO
• AUSTEDO remains the only vesicular monoamine transporter 2 (VMAT2) inhibitor available with 3-year data for this progressive condition1,2

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA),today announced final results from the HD cohort of the Phase 4 START study, demonstrating positive real-world effectiveness, safety, adherence and satisfaction with the 4-week Titration Kit for AUSTEDO. As a fatal, neurodegenerative disease, HD can cause cognitive deterioration, behavioral and/or psychological problems and uncontrollable body movements known as chorea – a symptom that can have a significant impact on daily activities like eating or talking.3-5 These data are being presented at the 2024 American Academy of Neurology (AAN) Annual Meeting.

"90% of HD patients experience chorea,3,4 so it's important for patients to have a treatment option that not only helps address symptoms, but helps provide a positive patient experience," said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. "We remain committed to exploring ways to evolve the AUSTEDO treatment experience to meet the needs of the HD community, and these latest real-world data reinforce the role of the 4-week Titration Kit for AUSTEDO in empowering patients with HD chorea to find their optimal dose, adhere consistently to their treatment plan, and achieve effective outcomes."

The START study was a Phase 4 study investigating real-world treatment outcomes for patients starting AUSTEDO with the 4-week Titration Kit. Final results from the HD cohort of the START study show that by week 24:

• 76% (13/17) of patients successfully completed the titration kit, with more than 90% adherence and a 33% mean reduction in total maximal chorea (TMC) score from baseline
• 53% (9/17) of patients achieved treatment success using the Clinical Global Impression of Change (CGIC) and 71% (12/17) using the Patient Global Impression of Change (PGIC)
• 100% (12/12) of patients who completed the satisfaction survey found the kit easy to use and 100% (7/7) of providers who completed the satisfaction survey found the kit helpful in ensuring patient adherence to the titration schedule

The safety profile of AUSTEDO in this study was consistent with the pivotal studies.

"These data demonstrate that we can have confidence in this treatment approach that allows patients to adjust their medication based on their individual HD chorea symptoms," said Karen Anderson, MD, Professor, Psychiatry and Neurology at Georgetown University School of Medicine and Director, Huntington's Disease Care, Education and Research Center. "I'm glad to see this outcome as it gives clinicians more confidence and patients more control."

About Chorea Associated with Huntington's Disease (HD)

Huntington's Disease (HD) is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems.3 Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of Huntington's disease and occurs in approximately 90% of patients.3,4 Chorea can have a significant impact on daily activities and progressively limit peoples' lives.3

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