What is WELTRUZA, the new once-monthly schizophrenia shot the FDA just approved?

WELTRUZA is a monthly under-the-skin form of olanzapine for adults with schizophrenia; it is a new treatment option, not a cure.

On Oct. 9, the FDA approved Teva’s WELTRUZA, an extended-release olanzapine suspension and the first once-monthly, under-the-skin long-acting form of olanzapine for adults with schizophrenia. Long-acting injectables exist because remembering a daily pill can be difficult, and missed doses can allow symptoms to return.

WELTRUZA is offered in 318, 425, and 531 mg strengths and, unlike older olanzapine injections, does not require loading doses, oral olanzapine supplementation, or hours of routine post-injection monitoring. In the Phase 3 SOLARIS trial, patients improved on the PANSS symptom scale, showed reduced illness severity on CGI-S, and improved personal and social functioning on PSP; its safety profile was consistent with oral olanzapine. Those results make it another treatment choice, not a cure.

A clinician should decide whether its dosing, metabolic risks, interactions, and follow-up needs fit an individual patient; no one should change schizophrenia treatment without the prescriber managing it.