TEL AVIV, Israel & PARIS, May 21, 2026
Teva Pharmaceuticals and Medincell have announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for TEV-‘749, an investigational long-acting injectable olanzapine therapy designed for the treatment of adults living with schizophrenia. The regulatory milestone marks a major advancement in Teva’s neuroscience portfolio and strengthens the company’s efforts to address treatment adherence challenges associated with chronic psychiatric disorders. The once-every-four-weeks subcutaneous injectable formulation is designed to provide the proven efficacy of oral olanzapine in a more convenient long-acting format, potentially addressing a significant unmet need within schizophrenia treatment across Europe and global healthcare markets.
TEV-‘749 Targets Long-Term Schizophrenia Management
According to Teva and Medincell, TEV-‘749 utilizes Medincell’s proprietary SteadyTeq™ copolymer delivery technology, enabling controlled and prolonged release of olanzapine following subcutaneous administration. The investigational therapy aims to improve medication adherence among schizophrenia patients who struggle with maintaining consistent daily oral treatment regimens, a longstanding challenge associated with relapse risk, hospitalization, and disease progression.
Schizophrenia affects approximately 0.3% to 1.5% of the European population, with many patients facing severe social, cognitive, and occupational impairments alongside significantly reduced life expectancy. Clinical experts continue to identify treatment nonadherence as one of the most critical barriers to successful long-term disease management. Studies have shown that nearly 80% of schizophrenia patients experience multiple relapses within the first five years of treatment, often resulting in emergency psychiatric care and hospitalization.
The MAA submission is supported by Teva’s extensive clinical development program, including the Phase 3 SOLARIS study, where TEV-‘749 demonstrated efficacy, systemic safety, and pharmacokinetic exposure consistent with oral olanzapine therapies. Company officials emphasized that the investigational long-acting injectable could provide a practical and effective alternative for patients requiring more stable long-term symptom management.
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Eric Hughes, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Teva, stated that treatment adherence remains one of the most significant challenges in schizophrenia care, particularly among patients dependent on oral antipsychotic medications. He noted that TEV-‘749 could help provide long-term therapeutic stability through a once-monthly injection while preserving the established efficacy and safety profile of olanzapine.
Long-Acting Injectable Therapies Gain Momentum
Long-acting injectable antipsychotics are becoming increasingly important within psychiatric medicine because they may improve treatment continuity, reduce relapse frequency, and lower hospitalization rates among patients with severe mental illness. Industry analysts continue to identify long-acting neuropsychiatric therapies as one of the fastest-growing areas within the global neuroscience pharmaceutical sector due to rising demand for patient-friendly treatment options that improve long-term outcomes.
Christophe Douat, Chief Executive Officer of Medincell, emphasized that olanzapine remains one of the most widely prescribed antipsychotic medications in Europe, but the lack of a practical long-acting olanzapine formulation has limited treatment flexibility for physicians and patients. He stated that TEV-‘749 may help address this unmet clinical need by offering a treatment option that fits more naturally into patients’ daily lives while supporting better long-term disease management.
The acceptance of the MAA by the EMA also reflects Teva’s broader strategic transformation under its “Pivot to Growth” initiative, which focuses on strengthening innovative medicines and complex therapeutic platforms across neuroscience, immunology, and specialty pharmaceuticals. The company continues expanding its presence in central nervous system disorders through advanced formulations, biologics, and long-acting drug delivery technologies.
Neuroscience Innovation Continues Expanding
The development of TEV-‘749 highlights the growing role of advanced drug delivery systems within psychiatric medicine and chronic disease management. Pharmaceutical companies increasingly view long-acting injectable technologies as critical tools for improving patient compliance, reducing healthcare costs, and supporting better real-world therapeutic outcomes in complex neurological and psychiatric disorders.
The EMA acceptance further positions Teva and Medincell among the leading innovators developing next-generation schizophrenia therapies designed to improve treatment accessibility, stability, and quality of life for patients living with severe mental health conditions worldwide.
Source: Teva Pharmaceuticals press release
