New FDA Filing for Potential Drug To Treat Chorea Associated with Huntington Disease 

The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for valbenazine (Ingrezza; Neurocrine Biosciences, San Diego, CA) as a treatment for chorea associated with Huntington disease (HD). The sNDA filing contained data from the KINECT-HD phase 3 study (NCT04102579) and the KINECT-HD2 open-label study (NCT04400331). Results from the KINECT-HD study showed improvements in the severity of chorea symptoms experienced by individuals with HD who were taking valbenazine compared with those taking a placebo. 

According to the filing, the FDA expects to make a decision by August 20. Data indicate that an estimated 90% of individuals diagnosed with HD report experiencing chorea, which is associated with involuntary spastic movements. 

"This sNDA filing advances our effort to bring a potential new treatment option to the many thousands of people experiencing chorea associated with HD in the US," said Eiry W. Roberts, MD chief medical officer at Neurocrine Biosciences. 

Valbenazine is currently available as the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for treatment of tardive dyskinesia (TD) that is available as a once-daily dose and does not require titration.