New FDA Approval: Simplified Treatment for Tardive Dyskinesia and Huntington's Disease Chorea

FDA Approves AUSTEDO XR for Once-Daily Treatment

Teva Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDO XR, a new once-daily extended-release tablet for treating Tardive Dyskinesia (TD) and chorea associated with Huntington's Disease (HD). This approval introduces four new tablet strengths: 30 mg, 36 mg, 42 mg, and 48 mg.

Since the debut of AUSTEDO in 2017, the medication has been crucial in managing chronic, involuntary movements in people with TD and HD. The latest approval aims to enhance simplicity and flexibility in dosing for patients who are on clinically therapeutic doses.

The Burden of Mental Illness in the United States

More than 57 million Americans currently live with a mental illness, and around 14 million have serious mental health conditions. Among those taking mental health medications, one in four may develop Tardive Dyskinesia, a movement disorder often overlooked but impactful in various physical, emotional, and psychological aspects of life.

Huntington's Disease, affecting about 90% of patients with its characteristic chorea, is a fatal neurodegenerative disorder that also brings cognitive and behavioral complications. Patients struggle with daily activities such as eating, talking, and walking due to these uncontrollable movements.

Enhanced Patient Experience with AUSTEDO XR

Dr. Rakesh Jain, Clinical Professor of Psychiatry at Texas Tech University, emphasized the importance of patient experience in managing TD and HD chorea. The once-daily option of AUSTEDO XR aims to provide patients with the same efficacy but with greater convenience, significantly impacting those who manage multiple conditions.

Clinical trials have shown that patients taking AUSTEDO XR for TD experience symptom improvement within two weeks, and those with HD chorea see significant improvements in their Total Maximal Chorea (TMC) scores.

Clinical Trial Data and Accessibility

AUSTEDO XR has been backed by extensive clinical trials showing sustained benefits and safety over three years. It is also notable as the only approved VMAT2 inhibitor for TD and HD chorea without restrictions for co-administration with CYP3A4/5 inducers or inhibitors, essential for patients on multiple medications.

Regarding affordability, around 90% of insured patients are expected to pay $10 or less for their prescriptions, with financial assistance available through Teva's programs.

Understanding TD and HD Chorea

Tardive Dyskinesia is characterized by uncontrollable and repetitive movements of the face, torso, and limbs, affecting one in four people on certain mental health treatments. These involuntary movements can significantly impact quality of life.

Huntington's Disease is marked by involuntary, random movements called chorea, cognitive decline, and behavioral problems, affecting approximately 90% of patients. This neurodegenerative disease progressively limits patients' abilities to engage in daily activities.

Conclusion

The approval of AUSTEDO XR marks a significant advancement in treating TD and HD chorea, offering increased dosing flexibility and a simplified regimen to improve patient outcomes.