Teva Pharmaceuticals, the U.S. division of Teva Pharmaceutical Industries Ltd. (TEVA), has announced the approval from the U.S. Food and Drug Administration (FDA) for AUSTEDO XR. This treatment, now available in four new dosage strengths (30, 36, 42, and 48 mg), is designed for once-daily administration and is indicated for adults suffering from tardive dyskinesia (TD) and chorea associated with Huntington's disease (HD).
For patients dealing with TD, AUSTEDO XR can offer symptom improvement within as little as two weeks. Meanwhile, those with HD chorea may observe a substantial reduction in their Total Maximal Chorea (TMC) score, as demonstrated in clinical trials extending up to three years, showcasing sustained beneficial effects.
Both AUSTEDO XR and its twice-daily formulation, AUSTEDO (deutetrabenazine), stand out as VMAT2 inhibitors without restrictions for use alongside CYP3A4/5 inducers or inhibitors. This flexibility is particularly crucial for patients managing multiple medications for various underlying conditions.
Financial assistance programs are anticipated to enable approximately 90% of insured patients to pay $10 or less for their prescriptions.
Tardive dyskinesia is a chronic and debilitating disorder marked by involuntary, irregular, and repetitious movements of the face, torso, and other body parts. It affects about one in four people taking specific mental health treatments, significantly disrupting their daily lives.
Huntington's disease is a fatal neurodegenerative disorder, characterized by uncoordinated, involuntary movements, cognitive decline, and behavioral or psychological issues. One of the most prominent symptoms is chorea, seen in approximately 90% of HD patients. Chorea is involuntary, unpredictable, and often twisting or writhing movements that severely impact the ability to perform daily activities.
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