TEVA Posts New SOLARIS Data on Monthly Olanzapine Shot Ahead of FDA Call
Post hoc analysis shows 56% of patients on TEV-'749 reached stabilization, with a PDUFA decision due in the fourth quarter of 2026.
Teva Pharmaceutical Industries (TEVA) presented new post hoc data from the pivotal Phase 3 SOLARIS trial of TEV-'749, an investigational once-monthly subcutaneous long-acting injectable formulation of olanzapine for schizophrenia in adults. The analyses, shown at Psych Congress in New Orleans from 15 to 19 September, cover the open-label long-term stage of the study plus simulations of how patients could switch from existing olanzapine regimens. An FDA decision on the product is expected in the fourth quarter of 2026.
