Teva wins FDA approval for monthly schizophrenia injection Weltruza
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Teva Pharmaceuticals has received FDA approval for Weltruza, a long-acting, once-monthly injection for adults with schizophrenia.
Teva said on Friday it had received approval from the US Food and Drug Administration for Weltruza (olanzapine), a once-monthly injection for adults with schizophrenia.
Weltruza is the second US-approved product from Israel-based Teva's partnership with French biotech company Medincell after Uzedy (risperidone), a long-acting injectable form of antipsychotic drug risperidone, which the FDA approved in 2023.
Teva, which leads the development and commercialisation of Weltruza, said it expected to launch the drug in the US in the coming weeks.
The product uses Medincell's long-acting injectable technology, which is designed to release medicines over extended periods.
The long-acting formulation of antipsychotic medicine olanzapine may help address treatment-adherence challenges in schizophrenia and other chronic psychiatric illnesses.
Medincell may be eligible for up to $112 million in additional development and commercial milestone payments under its agreement with Teva, along with royalties on sales.
Shares of Teva were up 2% in Tel Aviv at 1124 GMT; Medincell shares were suspended upon the company's request ahead of the announcement.
