FDA approves WELTRUZA for schizophrenia treatment

The U.S. Food and Drug Administration (FDA) has approved WELTRUZA, a once-monthly subcutaneous olanzapine injection for adults with schizophrenia. Developed by Teva Pharmaceutical Industries in partnership with Medincell, the treatment is designed to support stabilization without the need for loading doses, oral supplementation, or post-injection observation.

In Phase 3 clinical trials, the medication demonstrated improved symptom scores and personal/social functioning compared to a placebo. The approved product will be available in three strengths: 318 mg, 425 mg, and 531 mg. Common adverse events reported include increased weight, sleepiness, headache, constipation, and injection site reactions.

This marks the second FDA-approved medicine utilizing Medincell’s long-acting injectable technology. Under the partnership agreement, Medincell is eligible for mid- to high-single digit royalties on worldwide net sales, as well as up to $112 million in development and commercial milestones.