The U.S. Food and Drug Administration (FDA) has formally accepted a New Drug Application (NDA) from Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and Medincell for TEV-'749.

TEV-'749 is an investigational, once-monthly subcutaneous injection of olanzapine extended-release suspension developed for treating schizophrenia in adults. 

Currently, all FDA-approved long-acting olanzapine injections require a Risk Evaluation and Mitigation Strategy (REMS), meaning patients must be monitored in a certified facility for three hours post-dose. However, results from the Phase 3 SOLARIS trial for TEV-'749—a once-monthly subcutaneous injection—showed a safety and efficacy profile comparable to existing formulations but without any evidence that post-injection monitoring is necessary.

“Treatment adherence remains a major challenge and unmet need for people living with schizophrenia, including many who rely on oral forms of olanzapine. TEV-'749, our investigational subcutaneously delivered olanzapine LAI, has the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once-monthly treatment,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva.

“For too long, the lack of a viable long-acting olanzapine formulation has limited the options available to these individuals, and we look forward to working with the FDA on the review of this NDA for TEV-'749 to help address this gap in care.”

“Daily olanzapine is one of the most widely prescribed antipsychotics for people living with schizophrenia, and this long‑acting formulation may better fit into their lives,” said Christophe Douat, CEO of Medincell. “As experience with long‑acting injectables continues to grow, they are increasingly recognized as an important treatment option in serious psychiatric conditions. The potential reach of a practical long‑acting option is significant.”

The NDA for TEV-'749 is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia.1 The results demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations.

TEV-'749 is an investigational once-monthly subcutaneous LAI of the second-generation atypical antipsychotic olanzapine. It is not approved by any regulatory authority for any use at this time.

TEV-'749 utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.