Teva Reports Positive Long-Term IBD Data for Duvakitug, FDA Accepts TEV-749 Application
Teva and Sanofi reported durable 44-week efficacy for duvakitug in inflammatory bowel disease, while the FDA accepted Teva's application for TEV-749, a once-monthly olanzapine injection for schizophrenia.
In February 2026, Sanofi and Teva Pharmaceutical Industries reported that duvakitug, an investigational TL1A-targeting antibody, achieved durable 44-week clinical and endoscopic efficacy with consistent safety in ulcerative colitis and Crohn's disease responders in the RELIEVE UCCD long-term extension study. The novel biologic is currently undergoing clinical trial for UC and CD indications, with initial results suggesting it may potentially treat many different types of indications.
The US Food and Drug Administration has accepted Teva's New Drug Application for TEV-749, an olanzapine extended-release injectable suspension for the once-monthly treatment of schizophrenia in adults. TEV-749 is designed to improve real-world treatment adherence and help patients maintain long-term stability, with the goal of addressing a critical treatment gap for people living with schizophrenia.
Currently, there is no long-acting olanzapine formulation without an FDA-required Risk Evaluation and Mitigation Strategy (REMS), which mandates administration in a certified healthcare facility and requires a 3-hour post-injection monitoring period. In the Phase 3 SOLARIS trial, TEV-749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring.
The NDA for TEV-749 is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia. SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study. For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (TEV-749) (low, medium or high dose) or placebo in a 1:1:1:1 ratio. For period two (next 48 weeks), patients who completed period one were randomized and equally allocated to one of the three olanzapine LAI (TEV-749) treatment groups.
TEV-749 utilizes SteadyTeq, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine. The investigational once-monthly subcutaneous LAI of the second-generation atypical antipsychotic olanzapine is not approved by any regulatory authority for any use at this time.
Inflammatory bowel disease affects approximately 4.9 million people worldwide, and to date there isn't a cure. A debilitating condition, symptoms include weight loss, diarrhea, abdominal pain, rectal bleeding, and fatigue, and its prevalence is increasing worldwide. In partnership with Sanofi, Teva is developing a potential new treatment for IBD to address unmet patient needs.
Treatment adherence remains a major challenge and unmet need for people living with schizophrenia, including many who rely on oral forms of olanzapine. Daily olanzapine is one of the most widely prescribed antipsychotics for people living with schizophrenia. As experience with long-acting injectables continues to grow, they are increasingly recognized as an important treatment option in serious psychiatric conditions.
The duvakitug long term ulcerative colitis and Crohn's disease results sit alongside the FDA's acceptance of Teva's TEV-749 application for adult schizophrenia, both pointing to a broader specialty portfolio beyond AUSTEDO, AJOVY, and UZEDY. Now in its acceleration phase, Teva continues to step up innovation by working on breakthrough treatments for diseases that are on the rise worldwide, such as inflammatory bowel disease, multiple system atrophy, asthma and celiac disease.