Pooled phase III data on Ingrezza shows long term benefits in tardive dyskinesia.- Neurocrine Biosciences

Neurocrine Biosciences announced data from pooled analyses demonstrating the long-term benefit of the once-daily 40 mg dose of Ingrezza (valbenazine) capsules in reducing abnormal movements in adults with tardive dyskinesia (TD), a potentially irreversible and often persistent involuntary movement disorder. The analyses of pooled data from multiple long-term studies of the 40 mg dose showed that 53.7% of patients taking 40 mg of Ingrezza achieved an Abnormal Involuntary Movement Scale (AIMS) response (at least 50% improvement from baseline) after 48 weeks of treatment. Ingrezza is available in two doses, 40 mg and 80 mg. Additionally, an analysis of the pivotal Phase III KINECT 3 data demonstrated that 50% of patients achieved an early response after two weeks of Ingrezza treatment (40 mg or 80 mg). Data also showed that meaningful long-term reductions in TD were achieved regardless of whether patients responded after two weeks.

Data from pooled analyses of long-term clinical studies, KINECT 3 and KINECT 4, showed that 53.7% of patients taking 40 mg of Ingrezza (n=54) achieved an AIMS response (at least 50% improvement from baseline) after 48 weeks of treatment and 65.5% of patients (n=55) demonstrated a Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) response (defined as "very much improved" or "much improved"). Additionally, dose reductions from 80 mg to 40 mg did not appear to compromise the long-term benefit of Ingrezza. Neurocrine Biosciences also presented a post-hoc analysis of KINECT 3, the pivotal Phase III study, indicating that both the 40 mg and 80 mg doses of Ingrezza improved TD as early as two weeks in adults with TD, as measured by global clinician and patient scales. Results showed that 50% of patients (n=143) reached an early response threshold by patient-reported assessment (Patient Global Impression of Change [PGIC]; score less or equal to 3 at Week 2), while 43% achieved an early response by clinician judgement (CGI-TD; score less or equal to 3 at Week 2). Long-term reductions in TD symptom severity were meaningful regardless of early response as indicated by both PGIC and CGI-TD improvement.

In the studies, Ingrezza was generally well tolerated with no new safety concerns observed, and patients had no notable worsening of psychiatric symptoms. The most common adverse reactions (at least 5% and twice the rate of placebo) during the 6-week double-blind, placebo-controlled phase was somnolence. These long-term Ingrezza data were presented at the 2019 Annual Psych Congress.