Regulatory Decision Summary for Latuda
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Type of submission:
What was the purpose of this submission?
The sponsor submitted this application to establish the efficacy and safety of Latuda (lurasidone hydrochloride) for the treatment of depression associated with bipolar I disorder in adolescent patients (aged 10 to 17 years) based on the results of a randomized, parallel, double-blind, placebo-controlled, multicenter study of flexible dose of lurasidone (20 to 80 mg/day) over a six-week period (Study D1050326).
Why was the decision issued?
The submission included a pivotal 6-weeks, flexible dose, placebo-controlled, double blind study in adolescent patients diagnosed with bipolar I disorder. Doses (20 mg to 80 mg) of lurasidone were compared to placebo for improvement of depression using the Childrens Depression Rating Scale-Revised (CDRS-R). This scale is validated and commonly used in pediatric patients. The safety profile exhibited in this short-term study is similar to the profile in previous studies in adult patients. No new concerns were revealed and the already known concerns were generally not reported with greater frequency or severity. Knowledge of long-term exposure in children is limited.
The study demonstrated the efficacy of lurasidone in the treatment of depression in this patient population. The mean change (± SE) from baseline to endpoint (week 6) for the CDRS-R total score was -21.0 ± 1.06 for the lurasidone group compared with -15.3 ± 1.08 for the placebo group; favoring the lurasidone treatment (difference of -5.7 ± 1.39; adjusted p < 0.0001). The age range of patients in the study was 10-17 years of age.
The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) in adolescent patients treated with Latuda were nausea (16.0% vs. 5.8%), somnolence (11.4% vs. 5.8%), and weight increased (6.9% vs. 1.7%). These are well known adverse events and were not more frequent or severe than adults patients treated with Latuda.
The indication was limited to ages 13-17 due to the smaller number of patients to establish safety and efficacy between the ages of 10-12 in the trials. Currently, there is only one other atypical antipsychotic approved for pediatric use in Canada, Abilify. The indication for Abilify was also limited to 13-17 years of age for similar reasons.
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.