EMA Accepts Teva Application for Four-Week Olanzapine Injectable in Schizophrenia
European Medicines Agency has accepted Teva’s marketing application for TEV-749, a subcutaneous olanzapine long-acting injectable administered every four weeks for adult schizophrenia. If approved, TEV-749 would address the lack of long-acting olanzapine formulations and support Teva’s Pivot to Growth strategy.
1. EMA Accepts TEV-749 Marketing Authorization Application
The European Medicines Agency has formally accepted Teva’s Marketing Authorization Application for TEV-749, marking a key regulatory milestone. If approved, TEV-749 will offer adult patients a new long-acting injectable option for schizophrenia treatment.
2. TEV-749 Formulation and Dosing
TEV-749 is a subcutaneously administered olanzapine formulation designed for once-every-four-weeks dosing, leveraging controlled release to maintain therapeutic plasma levels. This long-acting profile aims to address adherence issues common with daily oral antipsychotics.
3. Clinical Development and Technology
The submission is supported by Phase 3 SOLARIS trial data demonstrating efficacy and systemic safety comparable to oral olanzapine. TEV-749 utilizes SteadyTeq™ copolymer technology to provide a steady, prolonged release of active drug over 28 days.
4. Market Opportunity and Strategic Impact
Schizophrenia affects up to 1.5% of the European population, with significant unmet needs for long-acting olanzapine options. Approval of TEV-749 would strengthen Teva’s leadership in neurological medicines and advance its Pivot to Growth biopharmaceutical strategy.