French biopharmaceutical company Medincell S.A. (Euronext Paris: MEDCL) announced on Friday that its partner Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd (NYSE:TEVA) (TASE:TEVA), has received US Food and Drug Administration (FDA) approval for WELTRUZA (olanzapine), the first and only once-monthly subcutaneous long-acting injectable formulation of olanzapine for adults with schizophrenia.

WELTRUZA requires neither loading doses nor oral supplementation at treatment initiation and eliminates the need for post-injection monitoring, addressing longstanding challenges in schizophrenia care.

The approval is supported by the Phase 3 SOLARIS trial, which demonstrated overall symptom improvement, reduced illness severity and improved personal and social functioning, with a systemic safety profile consistent with oral olanzapine.

Teva plans to launch WELTRUZA in the United States in the coming weeks, with monthly doses of 318 mg, 425 mg and 531 mg corresponding to daily oral olanzapine doses of 10 mg, 15 mg and 20 mg, respectively.

This approval marks the second FDA-approved medicine using Medincell's long-acting injectable technology, following UZEDY (risperidone) in 2023.

Medincell is eligible for mid- to high-single-digit royalties on worldwide net sales and up to USD112m in development and commercial milestone payments, including USD4m upon US approval and up to USD105m tied to specified sales thresholds.