Israeli pharmaceutical giant Teva announced Friday that the US Food and Drug Administration (FDA) has approved WELTRUZA, a new once-monthly injectable treatment for adults with schizophrenia.
The approval marks a significant milestone for the Israeli company, which has been expanding its innovative drug portfolio alongside its established generic pharmaceutical business.
WELTRUZA contains olanzapine, an antipsychotic medication widely used to treat schizophrenia. The new treatment uses sustained-release technology to deliver the medication gradually over a month through a single injection beneath the skin.
One of the treatment's main advantages is that, unlike certain existing long-acting olanzapine injections, it does not require patients to remain under mandatory medical observation following administration.
The change could make treatment more convenient for patients while reducing the burden on healthcare providers.
Schizophrenia is a chronic psychiatric disorder that can cause hallucinations, delusions, disorganized thinking, and difficulties with everyday functioning.
Consistent treatment is important for managing symptoms and reducing the risk of relapse and hospitalization. However, some patients struggle to maintain daily medication schedules, making long-acting injectable treatments an alternative.
WELTRUZA was developed in partnership with French biotechnology company Medincell, using its proprietary sustained-release technology.
Teva is responsible for the treatment's clinical development and commercialization and expects to launch the medication in the United States in the coming weeks.
The FDA's approval was based on results from the Phase 3 SOLARIS clinical trial, which included 675 adults with schizophrenia.
During the initial eight-week study, patients receiving WELTRUZA demonstrated statistically significant improvements in schizophrenia symptoms compared with those receiving a placebo.
Researchers also reported improvements in overall disease severity and patients' personal and social functioning.
Long-term safety data collected over 56 weeks, covering approximately 3,470 injections, found no suspected or confirmed cases of post-injection delirium and sedation syndrome (PDSS), a potentially serious complication associated with certain injectable olanzapine treatments.
Nevertheless, WELTRUZA may cause side effects, including weight gain, drowsiness, headaches, constipation, and reactions at the injection site.
As with other olanzapine-based medications, patients may also experience metabolic changes that require medical monitoring.
The treatment is not a cure for schizophrenia but provides another option for managing symptoms and maintaining consistent medication.
For Teva, the approval represents another achievement in its efforts to strengthen its innovative pharmaceutical business.
WELTRUZA will join UZEDY, the company's existing long-acting injectable schizophrenia treatment containing risperidone.
Teva is also seeking approval for WELTRUZA in Europe, where an application is currently under review by the European Medicines Agency.
The company expects the new treatment to offer patients who struggle with daily medication a more convenient option for managing their condition and maintaining long-term stability.