EMA Accepts Submission of Olanzapine LAI by Teva in Partnership with Medincell
The European Medicines Agency has accepted the marketing authorization application for Olanzapine LAI, a long-acting subcutaneous injection of olanzapine for the treatment of schizophrenia in adults. Teva and Medincell make a significant step forward in the development of this therapeutic candidate designed to improve treatment adherence in managing this chronic neuropsychiatric condition.
A Monthly Treatment to Enhance Therapeutic Adherence
Olanzapine LAI (TEV-749) delivers the effectiveness of oral olanzapine in the form of a monthly subcutaneous injection. This formulation employs SteadyTeq technology, a proprietary copolymer from Medincell that ensures controlled and sustained release of the active ingredient. According to the partners, the treatment addresses a major medical need: the lack of a viable long-acting olanzapine formulation currently limits therapeutic options. Adherence to therapy remains a central challenge for individuals with schizophrenia, particularly those dependent on daily oral forms.
Clinical Foundation and Therapeutic Positioning
The application submitted to the EMA is based on a robust clinical development program, including the phase 3 SOLARIS study. During its development, Olanzapine LAI demonstrated an efficacy and safety profile consistent with that of currently available oral olanzapine formulations. Schizophrenia affects between 0.3% and 1.5% of the European population. Approximately 80% of patients experience multiple relapses within the first five years of treatment. Long-acting injectable treatments are already widely used in Europe in the management of psychiatric disorders, which identifies a market for this new option.
