Teva Wins US FDA Approval for WELTRUZA Schizophrenia Treatment
Teva announced US FDA approval for WELTRUZA, a once-monthly extended-release injectable treatment for adults with schizophrenia, boosting its shares in pre-market New York trading.
Teva Pharmaceutical Industries announced that the US Food and Drug Administration (FDA) has approved WELTRUZA for extended-release injectable suspension. The company stated that this is a new long-term treatment administered via a single subcutaneous injection once a month for adults with schizophrenia.
Clinical trial results for WELTRUZA showed improvement in disease symptoms, a significant reduction in disease severity, and enhanced personal and social functioning, according to Teva. Teva's shares climbed in pre-market trading in New York following the announcement.
Dr. Eric Hughes, Executive Vice President, Global Head of Research and Development, and Chief Medical Officer at Teva, stated: "This approval reflects the strength of Teva's patient-focused innovation and our R&D organization's ability to deliver meaningful solutions for patients. WELTRUZA combines proven science with formulation innovation, eliminating the need for post-injection monitoring and addressing a major treatment barrier for adults living with schizophrenia."