FDA approves Ingrezza for chorea associated with Huntington’s disease
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The FDA has approved once-daily Ingrezza capsules for adults with chorea associated with Huntington’s disease.
According to a release from Neurocrine Biosciences Inc., the selective vesicular monoamine transporter 2 inhibitor Ingrezza (valbenazine, Neurocrine) can be adjusted by a patient's health care provider based on response and tolerability, with no complex titration.
Approval by the regulatory body was supported by data from two clinical studies conducted in collaboration with the Huntington Study Group, including the phase 3 randomized, double-blind, placebo-controlled KINECT-HD study, which included 128 adults aged 18 to 75 diagnosed with motor-manifest HD and associated chorea and the ongoing KINECT-HD2 open-label extension trial.
"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,” Neurocrine CEO Kevin C. Gorman stated in the release.
In KINECT-HD, data showed treatment with Ingrezza, which began at 40 mg, led to a 4.6-point improvement compared with a 1.4-point improvement with placebo in chorea severity score from baseline to week 12 and reduced chorea severity by approximately 40% from baseline to the treatment maintenance period. Almost half of participants logged reduction of more than 40% in chorea severity by week 12.
Additionally, according to statistics cited in the release, 53% of enrollees and 43% of health care professionals reported overall chorea symptoms were "very much improved" or "much improved" by week 12.
"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 vs. placebo seen at all subsequent visits," Erin Furr Stimming, MD, FAAN, FANA, principal study investigator, Huntington Study Group and professor of neurology, McGovern Medical, UTHealth Houston, said in the release.
Approved dosages for Ingrezza are 40 mg, 60 mg and 80 mg capsules, according to the release.