Teva Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted its New Drug Application for TEV-749, a once-monthly subcutaneous injection formulation of olanzapine for schizophrenia treatment. The submission is based on Phase 3 trial data from the SOLARIS study and represents the company's effort to address treatment adherence challenges in psychiatric care. If approved, the extended-release injectable would eliminate the need for post-injection monitoring, potentially reducing the burden on healthcare systems and patients.
The proposed monthly dosing regimen is designed to improve medication compliance compared to daily oral antipsychotics, a persistent challenge in schizophrenia management. The NDA acceptance triggers FDA review under standard timelines, bringing the candidate closer to potential market entry. Teva's submission builds on the established safety and efficacy profile of olanzapine, one of the most widely prescribed atypical antipsychotics globally.
Market reaction to the regulatory milestone was muted, with Teva shares declining 1.37% in premarket trading. The company now awaits FDA feedback during the review period as it competes in the long-acting injectable antipsychotic segment, which includes several established competitors offering monthly or quarterly dosing options.