Teva Wins FDA Approval for Monthly Schizophrenia Injectable WELTRUZA

Key Points

• FDA approval: Teva’s WELTRUZA, a once-monthly subcutaneous injectable formulation of olanzapine for schizophrenia, was approved without requiring a loading dose, oral supplementation or post-injection monitoring.
• Commercial launch: Teva set WELTRUZA’s wholesale acquisition cost at $2,950 and plans to target oral olanzapine users—especially those with adherence challenges—using its existing UZEDY sales infrastructure.
• Revenue ramp: Payer and hospital formulary access will determine uptake, with Teva expecting roughly 85% coverage within the first year and meaningful revenue mainly in the second half of the following year.

Teva Pharmaceutical Industries NYSE: TEVA said the U.S. Food and Drug Administration has approved WELTRUZA, a once-monthly subcutaneous long-acting injectable formulation of olanzapine for schizophrenia.

Chief Executive Officer Richard Francis said the approval represents another step in Teva’s “Pivot to Growth” strategy, which began in 2023 and is intended to expand the company beyond its generics business into biopharmaceutical products. Francis said 2026 had already included several development milestones, including FDA priority review for ecopipam and clinical updates involving dupilumab and anti-IL-15 programs.

WELTRUZA is designed to build on the established efficacy and safety profile of oral olanzapine while addressing medication adherence, according to Eric Hughes, Teva’s head of research and development and chief medical officer. The approved product is administered subcutaneously once a month and does not require a loading dose, oral supplementation or post-injection monitoring, the company said.

Focus on relapse prevention

Hughes described schizophrenia as a debilitating illness for patients and families, saying that preventing relapses can help avoid hospitalizations and disease progression. Teva estimates that 2.2 million people in the U.S. have schizophrenia, with approximately 1.5 million receiving treatment. About 20% of treated patients use oral olanzapine, according to the company.

Teva highlighted follow-on data from the SOLARIS study, in which the company said 4% of patients relapsed during a second study period extending to roughly one year. Hughes said the company believes a monthly injectable option may reduce adherence-related relapses for patients already benefiting from olanzapine.

“What WELTRUZA will bring, we hope, is that chance of decreasing relapses,” Hughes said. “By bringing an easily used subcutaneous injection that’s once a month, we’re chipping away at that adherence problem.”

Hughes also said WELTRUZA’s side-effect profile is identical to oral olanzapine’s profile, which he said gives physicians a familiar basis for selecting and monitoring patients. In response to questions about post-marketing obligations, Hughes said there are no unusual post-marketing commitments beyond pharmacovigilance monitoring and expedited reporting of suspected post-injection delirium/sedation syndrome, or PDSS, events.

Commercial launch plans and pricing

Francis said WELTRUZA will carry a wholesale acquisition cost, or WAC, of $2,950. Chris Fox, Teva’s executive vice president of U.S. Commercial, said the company chose a flat price across doses to avoid discouraging physicians from using a dose that a patient may need.

Teva expects to use its existing commercial infrastructure for UZEDY, its long-acting risperidone product, to support the WELTRUZA launch. Fox said about 80% of the physicians currently targeted by the UZEDY sales force are also expected to be WELTRUZA targets.

The company views patients using oral olanzapine, particularly those with adherence challenges, as the initial opportunity for WELTRUZA. Teva said some patients could potentially switch from other long-acting injectable antipsychotics, but it expects most early use to come from oral olanzapine.

Fox said the company expects product, samples and hospital kits to be available in the coming weeks and does not need to wait for a permanent J-code to launch. Teva also plans a direct-to-consumer campaign intended to increase awareness among patients, caregivers and physicians.

Coverage expected to build over time

Management said payer access, particularly among state Medicaid programs, will be an important determinant of the launch trajectory. Francis said some Medicaid coverage could begin immediately, while other states may take six to 18 months to add the product. Teva expects to have approximately 85% coverage by the end of the first year, he said.

The company also plans to pursue hospital formulary listings and Medicare coverage, while maintaining what it described as a balance between broad access and product value. Fox said Teva has established a patient-support hub to help patients navigate coverage and out-of-pocket costs, which will vary based on individual insurance status.

Francis said Teva does not expect significant WELTRUZA revenue during the first half of the following year, as payer coverage and hospital formulary access develop. He said meaningful revenue is expected in the second half, while early launch indicators will include samples, prescriptions, physician breadth and hospital adoption.

Teva has previously forecast combined annual revenue of $1.5 billion to $2 billion for UZEDY and WELTRUZA. Francis said the company intends to evaluate the pace of uptake and managed-care access before expanding on longer-term sales ambitions. Teva is also considering lifecycle-management opportunities for WELTRUZA, including a potential study in bipolar mania, Hughes said.

About Teva Pharmaceutical Industries (NYSE:TEVA)

Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company headquartered in Tel Aviv, Israel. Founded in 1901, the company develops, manufactures and distributes generic medicines, specialty pharmaceuticals, active pharmaceutical ingredients and biosimilars.

Teva's portfolio includes medicines for conditions affecting the central nervous system, respiratory system and other therapeutic areas. Its branded and specialty products include treatments such as Copaxone for multiple sclerosis, Austedo for movement disorders, Ajovy for migraine prevention and Uzedy for schizophrenia.

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