Teva Pharmaceuticals International and Medincell, have announced that the European Medicines Agency (EMA) has accepted the marketing application for their long-acting schizophrenia treatment candidate.

 

The Marketing Authorization Application is for olanzapine long-acting injectable (TEV-‘749), a proposed treatment for adults with schizophrenia.

 

If approved, TEV-‘749 would mark a shift toward long-acting care aimed at improving treatment adherence in real-world settings and supporting long-term disease management for people living with schizophrenia.

 

“Treatment adherence remains a challenge for people living with schizophrenia including those who rely on oral forms of Olanzapine. TEV-‘749, our investigational subcutaneously delivered olanzapine LAI, has the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once-every four weeks treatment,” said Eric Hughes, Executive Vice President, and Chief Medical Officer at Teva. 

 

“For too long, treatment options have been limited by the lack of a viable long-acting olanzapine formulation, and we look forward to working with the EMA to help address this gap in care.”

 

Medincell said the filing reflects a growing need for more practical treatment formats in Europe, where daily oral olanzapine remains widely prescribed and long-acting injectables are already a key tool in managing serious psychiatric illness.

 

“Daily oral olanzapine is one of the most commonly prescribed antipsychotics in Europe for people living with schizophrenia, and long-acting injectables are already well established in managing serious psychiatric conditions across the region,” said Christophe Douat, CEO of Medincell. 

 

“We believe a practical long-acting olanzapine option that fits more naturally into patients’ lives can help address a real and persistent need in schizophrenia.”

 

Schizophrenia affects an estimated 0.3–1.5% of the European population, with many patients facing severe social isolation, unstable employment, and a reduced life expectancy of 15–20 years.

 

TEV-‘749 is not yet approved in any country. Its EMA submission is supported by a clinical development program including the Phase 3 SOLARIS study, which reported efficacy, a safety profile consistent with systemic exposure, and pharmacokinetics aligned with oral olanzapine.

 

The drug candidate uses Medincell’s SteadyTeq technology, designed to enable a controlled, steady, and prolonged release of olanzapine.