Benzinga | Sep 1, 2021 07:49AM EDT

Teva-MedinCell's Schizophrenia Treatment Candidate Under FDA Review

* The FDA has accepted Teva Pharmaceutical Industries Ltd (NYSE:TEVA) and MedinCell's marketing application seeking approval for TV-46000/mdc-IRM in schizophrenia.

* TV-46000/mdc-IRM is a risperidone extended-release injectable suspension for subcutaneous use.

* The acceptance is based on Phase 3 data from two pivotal studies. Results will be shared at future scientific conferences and in peer-reviewed publications.

* Teva will continue to lead the clinical development and regulatory process and be responsible for the commercialization of this candidate treatment, with MedinCell eligible for development milestones, royalties on net sales, and future commercial milestones.

* Teva is also conducting another Phase 3 study designed to evaluate the long-term safety, tolerability, and effectiveness of TV-46000 subcutaneously administered for up to 56 weeks in 331 schizophrenia patients.

* The primary endpoint is the frequency of all adverse events, including serious adverse events. This study is ongoing; interim results align with the findings of the RISE study.

* Related content: Benzinga's Full FDA Calendar

* Price Action: TEVA shares are up 0.64% at $9.48 during the premarket session on the last check Wednesday.