Teva said on Friday it had received approval from the U.S. Food and Drug Administration for Weltruza, a once-monthly injection for adults with schizophrenia.
Weltruza is the second U.S.-approved product from Israel-based Teva’s partnership with French biotech company Medincell, after Uzedy, a long-acting injectable form of the antipsychotic drug risperidone, which the FDA approved in 2023.
Teva, which is leading the development and commercialization of Weltruza, said it expects to launch the drug in the United States in the coming weeks.
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The product uses Medincell’s long-acting injectable technology, designed to release medication over an extended period. Analysts see potential for long-acting antipsychotic formulations to help address treatment-adherence challenges among patients with chronic psychiatric conditions, as long-acting olanzapine formulations may do for people with schizophrenia.
Under its agreement with Teva, Medincell could receive up to $112 million in additional development and commercial milestone payments, as well as royalties on sales.
Teva shares closed 2 percent higher in Tel Aviv, while Medincell shares rose 16.9 percent in Paris.