FDA Approves Teva’s Austedo for Movement Disorders in Huntington’s Disease Patients

Rare Daily Staff

The U.S. Food and Drug Administration approved Teva Pharmaceuticals’ Austedo XR extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease.

Austedo XR is an additional formulation of the currently marketed twice-daily Austedo.

Huntington’s 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’s disease and occurs in approximately 90 percent of patients. Chorea can have a significant impact on daily activities and progressively limit peoples’ lives. Safety and effectiveness in pediatric patients have not been established.

Austedo XR/Austedo is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia (TD) and for the treatment of chorea associated with Huntington’s disease (HD). Austedo XR is the once-daily formulation of Austedo. TD is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.

“For some patients living with TD and HD, treatment adherence can be a challenge that this new once-daily dosing option can help to address,” said Eric Hughes, executive vice president of research and development and chief medical officer at Teva.

Once-daily Austedo XR has been shown to be therapeutically equivalent to the twice-daily formulation, providing another effective treatment choice. It will be available in three extended-release tablet strengths – 6 mg, 12 mg, and 24 mg – and can be taken with or without food. The new tablet strengths provide an updated regimen which may result in a decreased pill count for patients compared to the twice-daily formulation.

Austedo XR is expected to be available in the United States later this year.

Photo: Eric Hughes, executive vice president of research and development and chief medical officer at Teva