Regulatory Decision Summary for Latuda

Review decision

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.


Product type:

Drug

Medicinal ingredient(s):

lurasidone hydrochloride

Therapeutic area:

Psycholeptics

Type of submission:

Supplement to a New Drug Submission

Control number:

197342
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 schizophrenia in adolescent patients (aged 13 to 17 years) based on the results of a randomized, parallel, double-blind, placebo-controlled, multicenter study of fixed-doses of lurasidone (40 and 80 mg/day) over a six-week period (Study D1050301).

 

Why was the decision issued?

 

The submission included a pivotal 6-weeks, placebo-controlled, double blind study in adolescent patients diagnosed with schizophrenia. Two doses (40 mg and 80 mg) of lurasidone were compared to placebo for improvement on the Positive and Negative Syndrome Scale (PANSS). This scale is validated in adult patients and commonly used in pediatric patients. The safety profile exhibited in these short-term studies is similar to the profile in previous studies in adult patients. No new concerns were revealed and known concerns were generally not reported with greater frequency or severity. However, knowledge of long-term exposure is limited. An open-label extension of the pivotal study is ongoing and only an interim report is available. No safety concerns are revealed to date by the extension study.

The study demonstrated the efficacy of lurasidone in this patient population. The mean change (± SE) from Baseline to Week 6 of the PANSS score was -18.3 ± 1.60 for the lurasidone 80 mg/day group, -18.6 ± 1.59 for the lurasidone 40 mg/day group, and -10.5 ± 1.59 for the placebo group. Both the lurasidone 80 mg/day (-7.7 ± 2.22) and 40 mg/day (-8.0 ± 2.21) groups were significantly different from placebo (80 mg/day: adjusted p = 0.0008; 40 mg/day: adjusted p = 0.0006). While there was no difference in the primary outcome between the 40 mg/day and 80 mg/day mean treatment groups, some patients benefited from having the higher dose. The age range of patients in the study was 13-17 years of age. However, due to insufficient safety and efficacy data in adolescents less than 15 years, the indication for Latuda is limited to adolescents aged between 15 and 17 and adults.

A pharmacokinetics study demonstrated that doses of lurasidone of 80 mg and 40 mg were well tolerated and gave predictable exposure to the drug in pediatric patients. Doses above 80 mg were less well tolerated, were associated with increased adverse events (AEs) and with discontinuations due to AEs. Therefore, no doses above 80 mg were used in the pivotal study. Pharmacokinetic modelling indicates that exposure in these patients is similar to adults.

 

Decision issued

Approved; issued a Notice of Compliance pursuant to section C.08.004 of the Food and Drug Regulations