Teva wins FDA approval for WELTRUZA
- Teva Pharmaceutical Industries (NYSE:TEVA) received FDA approval for WELTRUZA, a once-monthly subcutaneous olanzapine injection for adults with schizophrenia.
- The treatment requires no loading dose, oral supplementation or post-injection monitoring and will be offered in three strengths.
- Teva expects U.S. availability within weeks, while its European application remains under review.
Teva Pharmaceutical Industries (NYSE:TEVA) received U.S. Food and Drug Administration approval for WELTRUZA, a once-monthly subcutaneous olanzapine injection for adults with schizophrenia.
Teva expects the treatment to become available in the United States within the coming weeks in 318 mg, 425 mg and 531 mg strengths.
The approval was based on the Phase 3 SOLARIS trial, which showed improvement in schizophrenia symptoms, reduced illness severity and better personal and social functioning.
Teva said WELTRUZA requires no loading doses, oral supplementation or post-injection monitoring, while weight gain and metabolic changes were consistent with oral olanzapine.
Discontinuations due to common adverse events were 5% with WELTRUZA versus 4% with placebo.
The treatment carries a boxed warning for increased mortality risk in elderly patients with dementia-related psychosis and is not approved for use in that population.
The European Medicines Agency accepted Teva’s application in May 2026, although WELTRUZA has not yet received approval in Europe.
