Teva announces EMA acceptance of MAA for olanzapine long-acting injectable

Teva (TEVA) Pharmaceuticals International announced that the European Medicines Agency has accepted the Marketing Authorization Application for olanzapine long-acting injectable for the treatment of schizophrenia in adults. TEV-‘749 aims to address treatment adherence in real-world settings and contribute to long-term disease management in people living with schizophrenia. TEV-‘749 is not approved by any regulatory authority worldwide at this time. The submission to the EMA is supported by an extensive clinical development program, including the Phase 3 SOLARIS study. Across clinical development, TEV-‘749 demonstrated efficacy, a systemic safety profile, and exposure consistent with oral olanzapine. TEV-‘749 utilizes SteadyTeq, a copolymer technology proprietary to Medincell that provides a controlled, steady, prolonged release of olanzapine.