Teva Pharmaceutical Industries (TEVA) FDA announcement summary

Introduction and purpose

• FDA approved WELTRUZA, the first and only once-monthly subcutaneous olanzapine LAI for adults with schizophrenia, addressing adherence challenges with daily oral treatment.

• Approval advances the Pivot to Grow strategy and supports the goal of building an innovative biopharmaceutical portfolio.

Details of approval or decision

• WELTRUZA is available in 318 mg, 425 mg and 531 mg strengths, corresponding to oral olanzapine doses of 10 mg, 15 mg and 20 mg.

• Approved dosing requires no loading dose, oral supplementation or post-injection monitoring.

• WAC price set at $2,950; flat pricing was intended to support broad access and avoid discouraging use of the clinically appropriate dose.

• No specific post-marketing commitment beyond routine pharmacovigilance and reporting of suspected PDSS.

Impact on industry and stakeholders

• U.S. estimates cite 2.2M diagnosed schizophrenia patients and 1.5M treated with oral antipsychotics; oral olanzapine represents ~20% of treated patients.

• WELTRUZA and UZEDY target different patient needs and could together offer an LAI option across ~80% of schizophrenia patients.

• Combined UZEDY and WELTRUZA forecast is $1.5B-$2B, contingent on access, clinical use and converting interest into prescriptions.

• WELTRUZA uses Medincell’s SteadyTeq copolymer technology for controlled, sustained olanzapine release.