Teva’s TEV-749 Extended-Release Olanzapine NDA Accepted by FDA
FDA has accepted Teva’s New Drug Application for TEV-749, a once-monthly extended-release injectable olanzapine based on Phase 3 SOLARIS data. The trial showed consistent efficacy and safety without post-injection monitoring, positioning TEV-749 to address adherence challenges in schizophrenia treatment.
1. FDA Acceptance of TEV-749 NDA
The U.S. Food and Drug Administration has accepted Teva’s New Drug Application for TEV-749, its olanzapine extended-release injectable suspension. This acceptance triggers a regulatory review that could lead to market authorization for a once-monthly schizophrenia treatment.
2. SOLARIS Trial Results
Phase 3 SOLARIS data demonstrated that TEV-749 achieved efficacy and safety profiles consistent with existing olanzapine formulations. Patients received a subcutaneous injection once per month without the need for post-injection monitoring, highlighting potential advantages in clinical practice.
3. Market Implications and Pipeline Impact
TEV-749’s acceptance enhances Teva’s schizophrenia portfolio alongside Uzedy, which generated $191 million in fiscal 2025 revenue. A long-acting formulation could boost adherence and capture market share in the chronic schizophrenia treatment segment.