Medincell: Teva unveils new data on its olanzapine, FDA decision expected end of 2026
Teva, Medincell's partner, presented new clinical and real-world data on two treatments based on the BEPO technology of the Montpellier-based biopharmaceutical company. These presentations were held at Psych Congress 2026, from September 15-19 in New Orleans.
Olanzapine LAI in phase 3: stabilization and long-term efficacy
Teva presented new post hoc analyses from the SOLARIS phase 3 study, evaluating its long-acting injectable olanzapine (LAI) administered once monthly via subcutaneous injection in the treatment of schizophrenia in adults.
During the long-term treatment period, 56% of participants achieved clinical stabilization. Among these stabilized patients, 4% subsequently experienced a relapse, while 21% of patients treated for at least six months met the study-defined remission criteria.
Additional analyses provided new insights into potential transition modalities from treatments with oral olanzapine or short-acting injectable formulations.
FDA decision expected in fourth quarter 2026
Olanzapine LAI is a treatment still in development, currently not approved by any regulatory authority. A decision from the United States Food and Drug Administration (FDA) is expected during the fourth quarter of 2026.
The marketing authorization application for olanzapine LAI as a monthly treatment for schizophrenia in adults was submitted to the FDA by Teva in December 2025, before its acceptance on February 20, 2026. A marketing authorization application in Europe was subsequently accepted by the EMA in May 2026.
UZEDY: superior treatment continuity in real-world settings
Teva also presented new real-world data on UZEDY, demonstrating improved treatment continuity in adults with schizophrenia compared to several other long-acting injectable antipsychotics, as well as a reduction in health resource utilization compared to monthly paliperidone palmitate.
Additional analyses evaluated outcomes observed in adults with type I bipolar disorder who transitioned from oral antipsychotic treatment to UZEDY. This treatment, licensed to Teva and commercialized in the United States, is based on Medincell's proprietary BEPO technology, licensed to Teva under the name SteadyTeq.
