FDA OKs Teva’s Monthly Olanzapine Injection; DuvaKitug Maintains 44-Week IBD Efficacy
Teva’s NDA for TEV-749, a once-monthly subcutaneous olanzapine extended-release injectable, has been accepted by the FDA to treat adult schizophrenia, showing no need for post-injection monitoring in Phase 3 SOLARIS. Teva and Sanofi also reported 44-week durable clinical and endoscopic efficacy for investigational duvakitug in ulcerative colitis and Crohn’s patients.
1. FDA Acceptance of TEV-749 NDA
The FDA has formally accepted Teva’s New Drug Application for TEV-749, an extended-release olanzapine injectable suspension designed for once-monthly subcutaneous administration in adults with schizophrenia. This formulation aims to eliminate the current requirement for administration in a certified facility and the associated three-hour post-injection monitoring period under the existing Risk Evaluation and Mitigation Strategy.
2. Phase 3 SOLARIS Trial Results
In the Phase 3 SOLARIS trial, TEV-749 demonstrated an efficacy and safety profile consistent with existing olanzapine formulations, with no adverse signals requiring post-injection monitoring. The data support improved real-world adherence and long-term stability for patients living with schizophrenia.
3. RELIEVE UCCD 44-Week Extension Data
In collaboration with Sanofi, Teva reported positive long-term data from the RELIEVE UCCD study of duvakitug, an investigational monoclonal antibody targeting TL1A, showing sustained clinical and endoscopic efficacy over 44 weeks in patients with ulcerative colitis and Crohn’s disease who responded to induction therapy.
4. Next Steps and Commercial Outlook
Teva will prepare regulatory submissions for TEV-749’s full review, potentially expediting a novel long-acting schizophrenia treatment. Positive duvakitug data bolster Teva’s inflammatory bowel disease pipeline, positioning both assets for future clinical and commercial milestones.