Neurocrine Biosciences Incorporated has announced the US Food and Drug Administration (FDA) approval for the use of valbenazine (Ingrezza®) capsules, designed to alleviate chorea, a characteristic movement disorder associated with Huntington disease (HD) in adults, according to a recently published press release.
Valbenazine is a selective vesicular monoamine transporter 2 inhibitor characterized by its adaptable dosing regimen, which differentiate it from similar drugs. The treatment offers an effective starting dosage that can be tailored to individual responses and tolerability. Valbenazine does not require a titration process, allowing a simple routine of only 1 capsule per day.
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The approval of valbenazine comes after several comprehensive clinical studies, including the pivotal KINECT-HD phase 3 trial and the ongoing KINECT-HD2 open-label extension study, provided robust evidence of the therapy’s efficacy.
The KINECT-HD Phase 3 trial was a randomized, double-blind, placebo-controlled investigation aimed to determine the efficacy and safety of the drug. The study accomplished its primary objective by demonstrating a statistically significant improvement in chorea severity using the total maximal chorea score of the Unified Huntington’s Disease Rating Scale, proving to be 3 times more effective than the placebo, with a substantial reduction in chorea severity.
Secondary outcomes from the KINECT-HD study included a 40% reduction in chorea severity from baseline to maintenance, with approximately half of the patients experiencing over 40% reduction in HD chorea severity by week 12. Over 50% of patients and 40% of healthcare professionals reported significant improvement in HD chorea symptoms.
Adverse effects associate with the drug include an increase of the risk for depression, suicidal ideation and behavior in patients with HD, as well as the potential for Neuroleptic Malignant Syndrome.
“Clinical results that led to this important approval showed reduction in the severity of chorea as early as 2 weeks after starting Ingrezza at an initial dose of 40 mg, with consistently greater improvements versus placebo seen at all subsequent visits,” said Erin Furr Stimming, MD, FAAN, FANA, the principal investigator of the Huntington Study Group and professor of neurology at McGovern Medical UTHealth in Houston, Texas.
“Data also demonstrated Ingrezza was generally well tolerated and showed clinically meaningful improvement in adults with chorea associated with HD,” she added.
This article originally appeared on Rare Disease Advisor
Neurocrine biosciences announces FDA approval of Ingrezza® (valbenazine) capsule for the treatment of chorea associated with Huntington’s disease. News release. Neurocrine Biosciences Incorporated; August 8, 2023.