Oct 9 (Reuters) – Teva 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 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
• 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
(Reporting by Lucie Barbier in Gdansk, editing by Milla Nissi-Prussak)
