Neurocrine Biosciences has achieved a significant milestone with the announcement of US Food and Drug Administration (FDA) approval for Ingrezza (valbenazine) capsules to treat chorea associated with Huntington’s disease (HD) in adults. Notably, Ingrezza stands as the sole selective vesicular monoamine transporter 2 (VMAT2) inhibitor that offers a streamlined starting dosage, adaptable based on patient response and tolerability, with a straightforward one-capsule, once-daily dosing regimen.
This pivotal FDA approval rests upon compelling evidence derived from two clinical studies conducted in partnership with the Huntington Study Group (HSG): the KINECT®-HD Phase 3 study and the ongoing KINECT®-HD2 open-label extension trial. The KINECT-HD study, a rigorously designed investigation, scrutinized the efficacy and safety of Ingrezza. Impressively, the study met its primary endpoint, showcasing statistically significant improvement in chorea severity using the Total Maximal Chorea (TMC) score of the Unified Huntington’s Disease Rating Scale (UHDRS) when comparing Ingrezza to placebo.
“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.”
– Kevin C. Gorman, Chief Executive Officer, Neurocrine Biosciences
The noteworthy outcomes from the KINECT-HD study include:
- A remarkable three-fold improvement in chorea severity with Ingrezza compared to placebo, evidenced by a 4.6-point improvement with Ingrezza against a 1.4-point improvement with placebo in the chorea severity score over the 12-week study period.
- Ingrezza effectively reduced chorea severity by approximately 40% from baseline to maintenance, with nearly 50% of patients experiencing a more than 40% reduction in HD chorea severity by Week 12.
- Notably, 53% of patients and 43% of healthcare professionals reported significant improvements in overall HD chorea symptoms at Week 12.
As with other FDA-approved treatments targeting HD-related chorea, the prescribing information for Ingrezza now includes crucial safety information related to serious risks such as depression, suicidal ideation and behavior in patients with Huntington’s disease, and the possibility of Neuroleptic Malignant Syndrome (NMS).
“Clinical results that led to this important approval showed reduction in the severity of chorea as early as two weeks after starting INGREZZA at an initial dose of 40 mg, with consistently greater improvements versus placebo seen at all subsequent visits. Data also demonstrated INGREZZA was generally well tolerated and showed clinically meaningful improvement in adults with chorea associated with HD.”
– Erin Furr Stimming, M.D., FAAN, FANA, Principal Investigator, Huntington Study Group and Professor of Neurology, McGovern Medical, UTHealth Houston
Throughout clinical studies in Huntington’s disease, some treatment-emergent adverse events observed included somnolence and sedation, urticaria, rash, and insomnia.
This accomplishment heralds a significant advancement in addressing the complex challenges posed by Huntington’s disease, offering patients a simplified dosing regimen alongside compelling evidence of effectiveness and safety. Neurocrine Biosciences’ INGREZZA has undoubtedly paved the way for a new era in the treatment of chorea associated with HD, reaffirming the company’s commitment to pushing the boundaries of medical innovation.
