Teva Pharmaceuticals, the U.S. arm of Teva Pharmaceutical Industries Ltd., and Medincell disclosed Friday that the FDA accepted their NDA filing for olanzapine extended-release injectable suspension, known as TEV-‘749. Officials described the subcutaneous shot as a potential game-changer for adults with schizophrenia.

No long-acting olanzapine formulation exists today without a Risk Evaluation and Mitigation Strategy program. That FDA mandate forces administration in certified healthcare settings. Patients must stay under observation for three hours after each injection to guard against rare but serious complications like post-injection delirium or sedation syndrome.

TEV-‘749 aims to change that. The Phase 3 SOLARIS trial tested it as a once-monthly subcutaneous injection. Data showed efficacy and safety matching oral and short-acting olanzapine versions. Crucially, trial results revealed no cases requiring post-injection syndrome monitoring, according to company statements.

Schizophrenia affects millions worldwide. Long-acting injectables help patients stick to treatment. They reduce relapse risks tied to missed daily pills. Olanzapine, a second-generation atypical antipsychotic, stands as one of the most effective options. Yet its current long-acting version carries heavy restrictions. TEV-‘749, if approved, would deliver olanzapine subcutaneously every four weeks without those burdens.

Teva and Medincell partnered on the drug’s development. Medincell provides its BEPO polymer technology for steady drug release. Teva handles manufacturing and commercialization in the U.S. The NDA submission followed positive SOLARIS results released earlier this year. Regulators now have until mid-2025 to decide, based on standard review timelines.

Richard Francis, Teva’s EVP and head of global R&D, called the acceptance a key step. "TEV-‘749 addresses a critical unmet need in schizophrenia care," he said in a prepared statement. Medincell CEO David Heaney echoed that view. He highlighted the therapy’s potential to improve patient outcomes and reduce healthcare system strain.

Wall Street took note. Teva shares (TEVA) ended Friday’s regular session at $34.22, down 0.32% or 11 cents. After-hours trading saw a sharper drop to $33.90, off 32 cents or 0.94% from the close.

Schizophrenia treatment lags behind other fields. Unlike ALS, where recent gene therapies have grabbed headlines, psychiatric drugs rarely see major leaps. Still, experts say injectables like TEV-‘749 could boost adherence rates, which hover below 50% for oral antipsychotics within a year of starting.

The FDA’s acceptance does not guarantee approval. Agency reviewers will scrutinize manufacturing data, trial details and labeling proposals. Past olanzapine injectables faced rejection or heavy restrictions over safety signals. Teva and Medincell expressed confidence based on SOLARIS findings.

Patients and advocates welcomed the news. The National Alliance on Mental Illness stressed the value of easier-to-use treatments. "Anything that cuts barriers to care helps," a spokesperson said.

Teva, based in Israel with major U.S. operations in Parsippany, New Jersey, leads in generic drugs and specialty pharmaceuticals. Medincell, a French biotech firm, specializes in long-acting injectables. Their collaboration dates back several years on this project.