WASHINGTON The Food and Drug Administration has approved Prestwick Pharmaceuticals’ drug Xenazine for treating chorea in people with Huntington’s disease.
Chorea is the jerky, involuntary movement that occurs in people with this disease. Xenazine (tetrabenazine) is the first treatment of any kind approved in the United States for any symptom of Huntington’s disease.
Huntington's disease is a rare, inherited neurological disorder affecting about 1 in 10,000 people in the United States that results from genetically programmed degeneration of brain cells. It causes uncontrolled movements, loss of intellectual faculties and emotional disturbance.
Xenazine has been approved with a required risk evaluation and mitigation strategy, or REMS, to ensure that the drug’s benefits outweigh its risks, particularly depression and suicidal thoughts and actions. REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product.
The REMS includes educational materials for prescribers, pharmacists, patients and caregivers to minimize harmful side effects. It also includes a medication guide, which informs patients and their caregivers about the risks of side effects. The FDA requires that the guide be handed out whenever the drug is dispensed.
About 30,000 people in the United States have Huntington’s disease, and another 200,000 are at risk of developing it.