EMA accepts Teva and Medincell’s MAA for TEV‑‘749, a once‑monthly long‑acting olanzapine injection, aiming to improve adherence in schizophrenia treatment across Europe.
By: Regulatory Desk
Teva Pharmaceutical Industries and Medincell announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for TEV-‘749, an investigational long-acting injectable olanzapine for adults with schizophrenia. If approved, the once-every-four-weeks subcutaneous formulation could provide a more practical long-acting olanzapine option in Europe.
Addressing Adherence Challenges
The program targets persistent adherence issues associated with daily oral antipsychotic therapy. Treatment discontinuation remains one of the strongest predictors of relapse in schizophrenia, contributing to hospitalization, functional decline, and recurrent psychiatric crises.
Long-acting injectable antipsychotics have become increasingly important in schizophrenia management, particularly for patients with recurrent relapse linked to inconsistent treatment adherence. While olanzapine remains one of the most widely prescribed antipsychotics in Europe, existing depot formulations have faced practical limitations that restricted broader uptake.
Technology Platform
TEV-‘749 combines olanzapine with Medincell’s proprietary SteadyTeq™ technology, a controlled-release copolymer system that enables sustained drug delivery over several weeks following subcutaneous injection. Clinical studies showed olanzapine exposure levels comparable to oral therapy while supporting once-monthly administration.
Clinical Evidence
The application is supported by the pivotal Phase 3 SOLARIS trial (NCT05693935) and additional studies evaluating efficacy, systemic safety, and tolerability. According to the companies, TEV-‘749 demonstrated efficacy and a systemic safety profile consistent with oral olanzapine across clinical development.
Schizophrenia Burden
Schizophrenia affects an estimated 0.3% to 1.5% of the European population and carries substantial clinical and social burden. Patients often experience hallucinations, delusions, cognitive impairment, and impaired daily functioning. Relapse rates remain particularly high during the first five years after diagnosis, with repeated episodes associated with progressive loss of function and increased healthcare utilization.
Executive Commentary
Eric Hughes, MD, PhD, Executive Vice President and Chief Medical Officer at Teva, said the investigational therapy could expand access to a practical olanzapine LAI for patients struggling with daily oral adherence. Medincell CEO Christophe Douat highlighted the established role of long-acting injectables in psychiatric care and emphasized the need for more practical olanzapine-based therapies.
Regulatory Path Ahead
TEV-‘749 remains investigational and has not received approval from any regulatory authority worldwide. The EMA review will determine whether TEV-‘749 can enter the European market as a once-monthly olanzapine injectable for adults with schizophrenia. The program also advanced in the United States, where the FDA accepted the New Drug Application for TEV-‘749 supported by data from the Phase 3 SOLARIS study.
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