By VETTAPHARMA reporter – Derek Roche: Teva Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-749) — an investigational, once-monthly long-acting injectable (LAI) treatment for schizophrenia in adults, a major cause of chronic disability worldwide. The application is supported by results from the Phase 3 SOLARIS trial, which demonstrate the product’s efficacy, safety, and tolerability in adults living with the condition.
TEV-749 is a once-monthly, subcutaneous LAI formulation of the second-generation antipsychotic olanzapine that uses SteadyTeq™ copolymer technology to provide controlled, sustained olanzapine release over a month, potentially improving real-world adherence and clinical stability compared with daily oral treatments.
The NDA acceptance follows submission of the Phase 3 SOLARIS study data, which evaluated TEV-749 in participants aged 18 to 64 years with schizophrenia. In the trial’s first 8-week period, 675 patients were randomized 1:1:1:1 to receive once-monthly injections of either low, medium, or high doses of TEV-749, or placebo. Participants completing this period entered a second 48-week treatment phase where they continued in the same dose groups. Efficacy, safety, and tolerability endpoints were met across the broad adult schizophrenia population studied.
Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva, said the company is committed to working closely with the FDA on the review of the olanzapine LAI application in hopes of addressing unmet clinical needs for people living with schizophrenia.
If approved, the olanzapine LAI could offer a once-monthly injectable option for schizophrenia, which is often marked by challenges in treatment adherence — a significant factor in relapse and hospitalization risk.
