FDA Approves Teva's Monthly Injection for Schizophrenia Treatment
Translated & summarized from Arutz Sheva by baba
The U.S. FDA has approved Teva's WELTRUZA, a new monthly injectable treatment for schizophrenia. Developed with Medincell, the drug uses SteadyTeq technology for sustained release of olanzapine without daily pills or post-injection supervision. The approval, based on the SOLARIS trial, aims to improve treatment adherence and symptom management for schizophrenia patients. Teva plans to launch the drug in the U.S. soon and is seeking European approval.
The story in 6 lines · by baba
- The FDA approved Teva's WELTRUZA, a monthly injectable treatment for schizophrenia.
- The drug utilizes SteadyTeq technology for sustained release of olanzapine over one month.
- Clinical trials showed significant improvement in symptoms and no cases of PDSS.
- WELTRUZA does not require prolonged medical supervision after injection.
- Teva plans to launch the treatment in the U.S. in the coming weeks.
- The company is also seeking marketing approval in Europe.
The U.S. Food and Drug Administration (FDA) has approved WELTRUZA, a novel monthly injectable treatment for schizophrenia developed by the Israeli pharmaceutical company Teva. This new therapy, utilizing the active ingredient olanzapine, allows for a single subcutaneous injection per month, potentially easing the burden for patients who struggle with daily medication adherence. Unlike some existing long-acting olanzapine formulations, WELTRUZA does not require prolonged medical supervision after administration, addressing concerns about a rare syndrome that can cause confusion and neurological issues.
Schizophrenia is a chronic mental disorder characterized by symptoms such as hallucinations, delusions, and impaired daily functioning. Maintaining consistent treatment is crucial to prevent relapse and hospitalization, making long-acting therapies a significant advancement in psychiatric care. WELTRUZA's innovation lies in its SteadyTeq technology, developed in collaboration with French biotech firm Medincell, which ensures a controlled, sustained release of olanzapine over the month.
The FDA's approval is based on the results of the international Phase III SOLARIS clinical trial, which involved 675 adult schizophrenia patients. The study demonstrated a statistically significant improvement in psychiatric symptoms across three different dosages of WELTRUZA compared to a placebo. Further data over 56 weeks, involving 3,470 injections, showed no suspected or confirmed cases of post-injection delirium and sedation syndrome (PDSS).
While WELTRUZA offers a new treatment option, it is not without side effects, including weight gain, somnolence, headaches, constipation, and local injection site reactions. Metabolic changes and significant weight gain, common with olanzapine-based treatments, also require appropriate medical monitoring. Teva emphasizes that the drug aims to manage symptoms and ensure treatment continuity, not to cure schizophrenia.
Teva plans to launch WELTRUZA in the United States in the coming weeks, offering it in three dosages: 318, 425, and 531 milligrams. This approval marks a strategic business achievement for Teva, reinforcing its position in the long-acting psychiatric drug market, where it also markets UZEDY (risperidone-based). The company is also seeking approval for WELTRUZA in Europe, having submitted its application to the European Medicines Agency (EMA) in May.
