Teva wins FDA approval for monthly schizophrenia injection Weltruza
Teva (TEVA.TA), opens new tab said on Friday it had received approval from the US Food and Drug Administration for Weltruza, 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 (MEDCL.PA), opens new tab after Uzedy, 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
Analysts see potential for long-acting antipsychotic formulations to help address treatment-adherence challenges in chronic psychiatric illnesses, as long-acting olanzapine may in schizophrenia
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 closed 2% higher in Tel Aviv; Medincell closed 16.9% higher in Paris
