Ingrezza Approved for the Treatment of Chorea Associated with Huntington Disease
Ingrezza (valbenazine; Neurocrine Biosciences, San Diego, CA) has received approval from the Food and Drug Administration (FDA) for the treatment of adults with chorea associated with Huntington disease (HD). The agent, delivered as a once-daily capsule, is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor also approved by the FDA for the treatment of adults with tardive dyskinesia. Chorea, a symptom associated with HD, is characterized by unpredictable, irregular movements.
FDA approval was based on results from the KINECT-HD (NCT04102579) phase 3, randomized, double-blind, placebo-controlled study, which assessed the efficacy, safety, and tolerability of Ingrezza in the treatment of HD-associated chorea in 128 adult participants aged 18 to 75 years from 46 Huntington’s Study Group (HSG)-credentialed sites across North America. Participants received a capsule of Ingrezza or placebo once daily for 12 weeks. The primary outcome was change from baseline in Unified Huntington’s Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) score. Secondary outcomes assessed differences from baseline in Clinical Global Impression of Change (CGI-C), Patient Global Impression of Change (PGI-C), and quality of life measures. Participants who received Ingrezza improved by 4.6 points in UHDRS TMC scores vs 1.4 points of improvement for placebo, meeting the study’s primary endpoint with significant chorea severity improvement. Common treatment-emergent adverse events (TEAEs) included somnolence, sedation, urticaria, rash, and insomnia. Ingrezza’s prescribing information contains a black box warning for the risk of depression and suicidal ideation.
“We are proud to bring Ingrezza to people living with HD and their caregivers who now have the option of a one-capsule, once-daily treatment that has demonstrated significant improvement in HD chorea in clinical studies,” said Kevin C. Gorman, Chief Executive Officer of Neurocrine Biosciences.
An open-label extension study, KINECT-HD2 (NCT04400331), is ongoing and recruiting adult participants with HD-associated chorea symptoms to assess TEAEs associated with administration of Ingrezza for up to 156 weeks as a primary outcome. Change from baseline in UHDRS TMC score is being evaluated as a secondary outcome.