VIDEO: Valbenazine improves chorea in Huntington’s disease

Editor’s note: This is an automatically generated transcript, which has been slightly edited for clarity. Please notify editor@healio.com if there are concerns regarding accuracy of the transcription.

Yes, in fact, on August 18th, 2023, the FDA approved Valbenazine, or INGREZZA, for the treatment of chorea in adults with Huntington’s disease. The FDA’s decision was based on data from the KINECT-HD and the KINECT-HD2 clinical trials. KINECT-HD was a phase three, double-blind, placebo-controlled clinical trial that evaluated the safety and efficacy of Valbenazine in adults with Huntington’s-related chorea. In the KINECT-HD study, the effects of Valbenazine on chorea were actually seen as early as 2 weeks after starting Valbenazine at the first dose level, which was 40 milligrams, with greater improvements versus placebo seen at all subsequent visits in weeks 4 through 12. KINECT-HD actually met its primary endpoint, and in fact Valbenazine demonstrated a three times greater improvement in chorea severity compared to placebo with a 4.6 point improvement seen with Valbenazine versus a 1.4 point improvement with placebo in the total maximal severity score, which is a component of the total motor score of the unified Huntington’s Disease Rating Scale which is an objective measure that evaluates the severity of motor and non-motor symptoms in individuals with HD. So that difference in chorea was highly statistically significant and that was compared the scores from the screening baseline period to those at the end of the 12-week clinical trial. The KINECT-HD2 study is an ongoing open-label study of those who continue Valbenazine that were in the KINECT-HD study and/or de novo patients, or participants I should say. I will mention in talking about the positive results from the clinical trial, there were, of course, treatment-emergent adverse events and the most common of those were somnolence, sedation, urticaria, rash and insomnia. But we’re excited about FDA approval of Valbenazine, which is the third in the class, the VMAT2 inhibitors, that has been approved specifically for Huntington’s-related chorea.