Regulatory Decision Summary for Brexpiprazole (*Rexulti)

Decision issued

No decision was issued by Health Canada. The company chose to cancel its submission before a final decision was issued.

Date of cancellation

June 17, 2022

What was the purpose of this submission?

The aim of the Supplement to a New Drug Submission (SNDS) was to seek approval for the use of Rexulti (brexpiprazole) for the treatment of schizophrenia in adolescent patients aged 13 to 17 years.

What did the company submit to support its submission

The submission included a clinical package and an updated risk management plan. The clinical package to support the use of Rexulti for the treatment of schizophrenia in adolescent patients included two Phase I pharmacokinetic (PK) studies, a population-PK analysis and two ongoing Phase III studies, a randomized, double-blind, placebo- and active-controlled trial and a long-term, multicenter, open-label trial.

What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?

At the time of the cancellation, the review was ongoing; however, Health Canada had identified deficiencies. Specifically, the submitted data were considered preliminary and lacking controlled evidence to establish the efficacy and safety of brexpiprazole in the proposed pediatric population, as the Phase 3 trials are still ongoing. Upon notifying the sponsor of the identified deficiencies, the sponsor chose to cancel their submission.

The product remains on the market, with no change to its indication.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

There is no expected impact for patients using SAP or in clinical trials.

Additional information

*Proposed Brand Name:

Rexulti