Teva Wins FDA Approval For Schizophrenia Innovation

As World Mental Health Month draws global support for people with mental health conditions, healthcare providers are focusing on patient-centric drug innovation to provide a wider range of comfortable, accessible treatment options.

The FDA approval of Weltruza, produced by leading generic pharmaceutical provider Teva, signifies a milestone within schizophrenia treatment.

Teva describes Weltruza as the first once-monthly subcutaneous olanzapine formulation for adults with schizophrenia: combining the antipsychotic with long-acting injectable technology, it offers an alternative to daily oral medicines, which patients can face difficulty adhering to.

“I’m incredibly proud of our R&D team and everyone across Teva who helped make this possible,” writes Eric A. Hughes, CMO and Head of R&D at Teva, on LinkedIn. “I’m especially grateful to the patients who participated in our clinical trials and the investigators who partnered with us along the way.”

For Teva, Weltruza’s impending rollout represents a significant strategic achievement as the pharmaceutical company pivots towards developing its pipeline of innovative medicines.

A patient-friendly schizophrenia treatment

For people living with schizophrenia, maintaining a treatment plan involves navigating appointments, medication routines, side effects and the practical demands of everyday life.

Traditional treatment centres around daily oral doses of antipsychotic formulations to reduce symptoms, which include disruptive hallucinations and delusions. However, maintaining a consistent administration schedule can present a challenge, increasing the risk of relapse. 

“Adherence continues to be a major barrier to stability,” explains Christoph Correll, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell. 

Olanzapine is also available as an intramuscular injectable, but administration requires post-injection monitoring and oral supplementation, which can prove disruptive. 

Weltruza is an extended-release injectable suspension, delivered once a month. The drug’s delivery platform uses SteadyTeq, a proprietary copolymer technology developed by Medincell, to enable controlled, sustained release of olanzapine. 

Requiring no loading doses, extended monitoring periods or additional booster medications, Teva aims to offer a lower-risk, reduced-disruption treatment option.

For some patients, Weltruza could provide a more accessible treatment routine: one that fits more comfortably around work, family responsibilities and community engagement.

“Weltruza was developed with the patient in mind from day one,” says Chris Fox, Executive Vice President and Head of Innovative Franchise at Teva.

The FDA decision was supported by SOLARIS, an eight-week placebo-controlled Phase 3 trial.

Teva reports that Weltruza secured improvements across three clinical measures: the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression–Severity scale (CGI-S) and the Personal and Social Performance scale (PSP). These assess schizophrenia symptoms, overall illness severity and social functioning, respectively.

“It is a powerful demonstration of what is possible when the needs of the patient guide the development of a truly innovative medicine,” Chris continues.

“Pivot to Growth”: Teva’s portfolio shift 

For Teva, Weltruza’s approval represents more than a milestone in schizophrenia treatment; it also encompasses a milestone achievement within the company’s long-term growth strategy.

As a major generic drug provider, Teva faces several growth constraints, owing to a lack of flexibility and the effects of price erosion on generic margins.

In 2023, the company announced “Pivot to Growth” – its strategic shift towards innovative medicines, in order to broaden its portfolio and secure new growth opportunities. 

The key targets of Teva’s strategy include:

• Target growth through innovative medicines, in order to reduce reliance on its traditional generics pipeline.
• Maintain generics as a core source of cash flow, while transferring research emphasis towards complex generics, biosimilars and higher-value opportunities.
• Prioritise R&D and develop differentiated treatments in areas like neuroscience and immunology to invest in long-term growth.
• Reduce costs by US$700m by simplifying operations and improving profit margins.
• Secure over US$5bn in innovative medicines revenue by 2030.

By scaling its existing novel medicines – including Austedo for involuntary movements and Ajovy for migraine prevention – Teva secured a 6% increase in revenues by 2024, and by 2025 its innovative portfolio constituted 30% of its core growth. 

The approval of Weltruza marks a significant step as the company continues to diversify its product pipeline and expand its presence in neuroscience.

“This milestone truly reflects our Pivot To Growth strategy in action: accelerating our innovative pipeline through disciplined execution and translating promising science into meaningful therapies,” concludes Richard Francis, CEO of Teva, discussing Weltruza’s approval on LinkedIn. 

“Together, we are continuing to build momentum across our innovative medicines portfolio to deliver impact where patients need it most.”

Teva’s key partners

MedinCell

CEO: Christophe Douat | HQ: Jacou, France

Medincell is a biopharmaceutical company based in France that develops long-acting injectable medicines using proprietary technologies. Its SteadyTeq platform enables controlled, sustained drug release and underpins Weltruza. Medincell collaborates with Teva on long-acting injectable treatments, with Weltruza following UZEDY as a second US-approved medicine arising from their partnership. 

The Zucker School of Medicine

CEO: Michael J. Dowling | HQ: Hempstead, NY

The Zucker School of Medicine at Hofstra/Northwell is a medical school in New York affiliated with Northwell Health. Psychiatrist Christoph Correll, a clinical professor at the school, served as coordinating investigator for the SOLARIS clinical programme supporting Weltruza's development. The academic and clinical research setting connects the medicine's development with evidence generation in schizophrenia.

Samsung Bioepis

CEO: Kyung-Ah Kim | HQ: Incheon, South Korea

Samsung Bioepis is a biopharmaceutical company focused on developing biosimilar medicines. Its strategic partnership with Teva covers the development and commercialisation of biosimilar candidates in agreed markets. Samsung Bioepis leads development, regulatory registration and manufacturing under the arrangement, while Teva leads commercialisation.