FDA Approves Neurocrine’s Ingrezza for Chorea Associated with Huntington’s Disease

Rare Daily Staff

The U.S. Food and Drug Administration has approved Neurocrine Biosciences’ Ingrezza capsules for the treatment of adults with chorea associated with Huntington’s disease.

Huntington’s disease (HD) is a hereditary progressive neurodegenerative disorder in which the loss of certain neurons within the brain causes motor, cognitive and psychiatric symptoms. Symptoms generally appear between the ages of 30 and 50 years and worsen over a 10- to 25-year period. Most people with HD experience chorea, an abnormal involuntary movement disorder, characterized by irregular and unpredictable movements. Chorea can affect various body parts and interfere with motor coordination, gait, swallowing and speech. HD is estimated to affect approximately 41,000 adults in the United States, with more than 200,000 at risk of inheriting the disease.

Ingrezza is the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor that offers an effective starting dosage that can be adjusted by a patient’s healthcare provider based on response and tolerability, with no complex titration.

The FDA approval is supported by data from two clinical studies conducted in collaboration with the Huntington Study Group (HSG), including the KINECT-HD phase 3 study and the ongoing KINECT-HD2 open-label extension trial. KINECT-HD, a randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of Ingrezza, met its primary endpoint of least squares mean (LSM) change in chorea severity using the Total Maximal Chorea (TMC) score of the Unified Huntington’s Disease Rating Scale (UHDRS) from screening period baseline to maintenance period (average of Weeks 10 and 12), demonstrating a statistically significant greater improvement in TMC score with Ingrezza versus placebo.