Rather than taking olanzapine by mouth every day, patients receive Weltruza as an injection under the skin once a month.
By Shula Rosen
Israeli drugmaker Teva has won FDA approval for a new schizophrenia treatment that replaces daily pills with a single injection each month, offering patients another way to manage a condition in which staying on medication can be a persistent challenge.
The treatment, called Weltruza, is a long-lasting form of olanzapine, a drug that has been prescribed for schizophrenia for more than 30 years.
Rather than taking olanzapine by mouth every day, patients receive Weltruza as an injection under the skin once a month.
That difference could be significant for people who have difficulty keeping up with a daily medication schedule.
Olanzapine is the most widely prescribed atypical antipsychotic in its oral form, but missed doses can make it harder for patients to remain stable.
Weltruza also avoids some of the complications associated with previous long-lasting versions of olanzapine.
Patients do not need additional oral medication while beginning treatment, extra initial doses or booster injections.
They also do not have to remain under observation after receiving the injection.
Older injectable versions have required patients to be monitored for three hours because of the risk of post-injection delirium/sedation syndrome, or PDSS. The condition can cause confusion, anxiety, agitation and severe drowsiness.
“Olanzapine has been a trusted and foundational treatment option for people living with schizophrenia for more than 30 years, but adherence continues to be a major barrier to stability, particularly for those who rely on daily oral medications,” said Christoph Correll, MD, of the Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York.
FDA approval was supported by the Phase 3 SOLARIS clinical trial, which found improvements in schizophrenia symptoms, the severity of patients’ illness and their ability to function socially and in their daily lives.
Teva developed Weltruza with French biotech company Medincell. It is the second U.S.-approved treatment produced through their partnership, following Uzedy, a long-lasting injectable version of the antipsychotic risperidone approved in 2023.
Weltruza will come in three doses corresponding to commonly prescribed oral doses of olanzapine. Teva expects the treatment to become available in the United States in the coming weeks.
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