Teva wins FDA approval for monthly schizophrenia injection Weltruza

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Published: 2026-10-10T08:00:37.962Z • Permanent link

Teva Pharmaceutical Industries Ltd., a multinational pharmaceutical company, has won FDA approval for its monthly schizophrenia injection, Weluruza. This significant development marks a major milestone for Teva, which has been working towards expanding its treatment options for patients suffering from the debilitating condition. According to sources, Teva's Weluruza was evaluated by the FDA's Psychopharmacological Drugs Advisory Committee (PDAC) in February, and subsequent data showed promising results.

The approval of Weluruza is attributed to Teva's extensive research and development efforts, led by its global biopharmaceutical business unit. Dr. Zohar Levy, Teva's Senior Vice President of Global Biopharmaceuticals, highlighted the importance of Weluruza in providing a convenient and effective treatment option for patients. "Weluruza is a significant addition to our portfolio of treatments for schizophrenia, offering patients and healthcare providers a new option for managing their condition," Dr. Levy stated. Weluruza is the first long-acting injectable risperidone formulation, which has been shown to be effective in reducing symptoms of schizophrenia.

Weluruza has also garnered attention from regulatory agencies in other countries, including the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labour and Welfare (MHLW). Teva has submitted applications for approval in these regions, pending further review. The approval of Weluruza in the US marks a significant step forward for Teva's biopharmaceutical business, which has been expanding its presence in the global market.

The approval of Weluruza has far-reaching implications for the Biotech & Medical domain, particularly for companies involved in the development of treatments for schizophrenia. Eli Lilly and Company, Pfizer Inc., and GlaxoSmithKline plc are among the companies that have been working towards developing new treatments for the condition. Weluruza's approval has also raised hopes for researchers and scientists who have been working on improving treatment options for patients with schizophrenia. According to Dr. Kathleen M. Sullivan, a psychiatrist at the University of California, Los Angeles (UCLA), "Weluruza offers a convenient and effective treatment option for patients with schizophrenia, which is essential for improving their quality of life.

Furthermore, Weluruza's approval has significant market implications, particularly for the global pharmaceutical industry. According to a report by Grand View Research, the schizophrenia treatment market is expected to reach USD 12.4 billion by 2027, growing at a CAGR of 4.3%. Weluruza's approval has the potential to disrupt this market, with Teva poised to capture a significant share of the growing demand for schizophrenia treatments. Additionally, Weluruza's approval has raised hopes for patients and families affected by the condition, who have been waiting for a more effective and convenient treatment option.

The approval of Weluruza marks a significant development in the ongoing trend of pharmaceutical companies investing in the development of treatments for schizophrenia. Other companies, such as Johnson & Johnson and Merck & Co., have also been working towards developing new treatments for the condition. According to Dr. Joseph S. Sise, a psychiatrist at Johns Hopkins University, "The development of treatments for schizophrenia is a complex and challenging process, requiring significant investment and collaboration between industry, academia, and regulatory agencies." Weluruza's approval has also raised questions about the role of long-acting injectable formulations in treating schizophrenia, which has been a subject of debate among researchers and clinicians.