US-based Neurocrine Biosciences has received approval from the US Food and Drug Administration (FDA) for Ingrezza (valbenazine) capsules to treat adults with chorea associated with Huntington’s disease (HD).
Ingrezza is an only one-capsule, once-daily selective vesicular monoamine transporter 2 (VMAT2) inhibitor.
It is said to be the only VMAT2 inhibitor that provides an effective starting dosage which can be modified by a patient’s healthcare provider as per the response and tolerability, with no complex titration.
The US FDA granted the approval based on the data from the KINECT-HD Phase 3 study and the ongoing KINECT-HD2 open-label extension trial.
Both studies were conducted in collaboration with the Huntington Study Group (HSG).
KINECT-HD is a randomised, double-blind, placebo-controlled study that assessed the efficacy and safety of Ingrezza. The Total Maximal Chorea (TMC) score of the Unified Huntington’s Disease Rating Scale (UHDRS) was used as the primary endpoint.
The trial met its primary endpoint of least squares mean (LSM) change in chorea severity using the TMC score of the UHDRS from the screening period baseline to the maintenance period.
The biopharmaceutical company said that the results showed a statistically significantly greater improvement in TMC score with Ingrezza versus placebo.
Additionally, the VMAT2 inhibitor showed a three-times greater improvement in chorea severity compared to placebo.
The chorea severity was reduced by 40% from baseline to maintenance and nearly half of patients witnessed over 40% reduction in HD chorea severity by week 12.
Furthermore, 53% of patients and 43% of healthcare professionals said that the overall HD chorea symptoms were very much improved or much improved at week 12.
Neurocrine Biosciences CEO Kevin Gorman said: “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.
“We are thankful for those in the HD community who helped contribute to this important milestone, and we remain committed to bringing medicines to patients with unmet medical needs for debilitating neurological disorders.”
