Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) shares began Tuesday sharply higher. The company today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults.
The NDA for olanzapine LAI is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia. The results validated olanzapine LAI in meeting efficacy and safety endpoints in a broad adult population of people living with schizophrenia.
“The innovation of olanzapine LAI comes from its delivery of olanzapine, a foundational treatment for schizophrenia, as a once-monthly subcutaneous formulation,” said Chief Medical Officer Eric Hughes. “Teva is committed to working closely with the FDA on the review of this olanzapine LAI application as we seek to help address the critical unmet needs of people living with schizophrenia.”
Olanzapine LAI is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine. In the SOLARIS trial, it demonstrated an efficacy and safety profile consistent with currently available oral olanzapine formulations. It is not approved by any regulatory authority for any use at this time.
TEVA shares grabbed 74 cents, or 2.6%, to $29.07.
