Teva Pharmaceutical (TEVA) and its European partner Medincell (MDCLF) announced that the FDA has accepted their marketing application for a long-acting version of the antipsychotic medicine olanzapine, developed in partnership with Royalty Pharma (RPRX).
Specifically, the New Drug Application seeks the U.S. approval of olanzapine extended-release injectable suspension (TEV-‘749) to treat adults with schizophrenia with a once-monthly subcutaneous injection.
The NDA is supported by data from the companies’ Phase 3 SOLARIS trial, which demonstrated that patients on TEV-‘749 were not required to undergo post-administration monitoring.
The global trial for schizophrenia patients aged 18 – 64 years also indicated that the safety profile of TEV-‘749 as a once-monthly was in line with currently approved olanzapine versions.
The current long-acting olanzapine formulations are available with an FDA-mandated Risk Evaluation and Mitigation Strategy, which involves a three-hour post-treatment monitoring period, among other requirements.
“For too long, the lack of a viable long-acting olanzapine formulation has limited the options available to these individuals,” said Eric Hughes, chief medical officer of Teva (TEVA). “And we look forward to working with the FDA on the review of this NDA for TEV-‘749 to help address this gap in care.”