FDA Accepts Teva's NDA for Once-Monthly Olanzapine Injectable for Schizophrenia
The FDA has accepted Teva and Medincell's New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine formulation for schizophrenia treatment that showed no need for post-injection monitoring in Phase 3 trials.
Teva Pharmaceutical Industries and Medincell announced that the US Food and Drug Administration has accepted the New Drug Application for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. TEV-'749 is designed to improve real-world treatment adherence and help patients maintain long-term stability, with the goal of addressing a critical treatment gap for people living with schizophrenia.
TEV-'749 is an investigational subcutaneously delivered olanzapine long-acting injectable with the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once-monthly treatment. In the Phase III SOLARIS trial, TEV-'749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring.
Currently, there is no long-acting olanzapine formulation without an FDA-required Risk Evaluation and Mitigation Strategy (REMS), which mandates administration in a certified healthcare facility and requires a 3-hour post-injection monitoring period. Treatment adherence remains a major challenge and unmet need for people living with schizophrenia, including many who rely on oral forms of olanzapine.
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. The results demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations.
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia. For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (TEV-'749) (low, medium or high dose) or placebo in a 1:1:1:1 ratio. For period two (next 48 weeks), patients who completed period one were randomized and equally allocated to one of the three olanzapine LAI (TEV-'749) treatment groups. The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.
TEV-'749 utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine. TEV-'749 is not approved by any regulatory authority for any use at this time.
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts. Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability. Approximately 1% of the world's population will develop schizophrenia in their lifetime.